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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Class I Food Event

Event ID55288
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLL Bakery, Inc.
CityTorrance
StateCA
CountryUS
Distribution PatternHI, WA, and CA
 

Associated Products

Product DescriptionWhite Farm Enriched White Bread. 16 oz (454g), 9pc/box. UPC 0 10314 10002 0. The label is white with blue and green lettering and red design accents. The LL Bakery Logo is on the bottom left corner.
Code Infono lot codes
ClassificationClass I
Reason for RecallLL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements.
Product Quantity1020 units
Recall NumberF-1474-2013
Product DescriptionButter Farm Enriched White Bread 16 oz (454g), 9pc/box. UPC 0 10314 10004 4. The label is white with blue and green lettering and red design accents. The LL Bakery Logo is on the bottom left corner.
Code Infono lot codes
ClassificationClass I
Reason for RecallLL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements.
Product Quantity1020 units
Recall NumberF-1475-2013
Product DescriptionItalian Cream Danish 8.5 oz (240g), 14pc/box. UPC 0 10314 40056 4. The pastry is braided and has yellow creamy swirls and sliced almonds. The label is white with black lettering and a tan colored border. The LL Bakery Logo is on the bottom left corner.
Code InfoNot available
ClassificationClass I
Reason for RecallLL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements.
Product Quantity1020 units
Recall NumberF-1476-2013

Class I Devices Event

Event ID64631
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Xomed, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternWorldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.
 

Associated Products

Product DescriptionREF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
Code InfoProduct Catalog Numbers: REF 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739. Lot Numbers: 205830052 to 206486732. 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, 0206545502.
ClassificationClass I
Reason for RecallIn March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
Product Quantity2,591 units
Recall NumberZ-1420-2013

Class I Food Event

Event ID65132
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWhole Foods Market Group Inc.
CityEverett
StateMA
CountryUS
Distribution PatternMaine, Massachusetts, Rhode Island, Connecticut, New York, New Jersey
 

Associated Products

Product DescriptionWhole Foods Salad Chicken Curry , 1 lb plastic bag (bulk)
Code InfoSell By Date: 5/10/13
ClassificationClass I
Reason for RecallUndeclared allergen: egg
Product Quantity493 lbs
Recall NumberF-1469-2013
Product DescriptionWhole Foods Salad Curried Vegan Chick N , 1 lb plastic bags (bulk)
Code InfoSell By Date: 5/10/13
ClassificationClass I
Reason for RecallUndeclared allergen: soy
Product Quantity171 lbs
Recall NumberF-1470-2013

Class I Devices Event

Event ID65192
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSymbios Medical Products, LLC
CityIndianapolis
StateIN
CountryUS
Distribution PatternUS Nationwide distribution.
 

Associated Products

Product DescriptionPart 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH GoPump Kit 510110, w/2.5" Fenestrated Catheter GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication.
Code InfoPump 510031, Lot 11-l 00106 to Lot 12-101133 Kit 510042, lots 11-100251 to 13-100128 Kit 510042-BP , lot 12-101300 Kit 510110, lot 11-100664 Kit 510110-BP, Lots 11-100838 to 12-101560 Kit 510350, Lots 11-100353 to 12-100233 Kit 510350-BP, Lots12-100429 to 13-100047 Kit 510556-BP Lots 11-100779 to 12-101552
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity 33, 543 in all sizes/ kits
Recall NumberZ-1452-2013
Product DescriptionPart 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit 510141-BP,10" fenestrated catheter& BIOPATCH Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
Code InfoPump 510076 Lot 11-100222 to 12-101087 found in: Kit 510080 BP. Lot 11-100215 to 12-100508 Kit 510141-BP Lot 12-100460 to 12-100673 Kit 510112-BP, Lot 11-100839-to 13-100225
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantityall kits 33,543
Recall NumberZ-1453-2013
Product DescriptionPart 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate
Code InfoPump Part 510180, Lot 11-100453 to 12-101003 found in: Go Pump Kit 510201-BP. Lot 12-100108 to 12-101538 Go Pump Kit 510349-BP. Lot 12-100935 Go Pump Kit 510642, Lot 12-100616 to 13-100590
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantityall kits 33, 543
Recall NumberZ-1454-2013
Product DescriptionPart 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5" Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch GoPump Kit 510205BP, 5" Fenestrated catheter & Biopatch GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch GoBlock kit 510608 Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
Code InfoPump Part 510121, Lot 11-100081 to 12-101406 found in: Go Pump Kit 510203-BP. Lot 12-101301 to 13-101538 GoPump Kit 510204, Lot 11-100505 to 11-1-665 GoPump Kit 510204 BP, Lot 11-100721 to 13-100680 GoPump Kit 510205BP, Lot 11-100722 to 13-100087 GoBlock kit 510608
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity33,543 in all kits
Recall NumberZ-1455-2013
Product DescriptionPart510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
Code InfoGoPump Kit 510462-BP, Lot 11-100694- Lot 13-100092 GoPump Kit 510558-BP , Lot 12-100230 - Lot12-101343 GoPump Kit 510643, Lot 12-100332 - Lot 13-100183
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity34517 for all kits
Recall NumberZ-1456-2013
Product DescriptionPart 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
Code InfoPump Part 510449, Lot 11-100271 - Lot 130100137 found in: GoBlock Kit 510472, Lot 11-100385 to 13-100354
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity
Recall NumberZ-1457-2013
Product DescriptionPart 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable Single Infusion Pump
Code InfoPump Part 510450, Lot 11-100351- Lot 12-101243 found in: GoBlock Kit 510458, Lot 11-100618 to 13-100703
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity33, 543 for all kits
Recall NumberZ-1458-2013
Product DescriptionPart 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery
Code InfoPump Part 510490, Lot 11-100379- Lot 12-101132 found in: GoBlock Kit 510491, Lot 11-100601 to 13-100705
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity33, 543 for all kits
Recall NumberZ-1459-2013
Product DescriptionPart 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
Code InfoPump Part 510613 , Lot 11-100136- Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity33,543 all kits
Recall NumberZ-1460-2013
Product DescriptionPart 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
Code InfoPump Part 510613 , Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity33,543 all kits
Recall NumberZ-1461-2013
Product DescriptionPart 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
Code InfoPump Part 510636 , Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646, Lot 11-100632- Lot 12-101233
ClassificationClass I
Reason for RecallSymbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Product Quantity33543
Recall NumberZ-1462-2013

Class II Biologics Event

Event ID44326
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross
CityBoise
StateID
CountryUS
Distribution PatternUtah.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info020H06535
ClassificationClass II
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1 component
Recall NumberB-1281-13

Class II Biologics Event

Event ID47061
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternOregon and California.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info021FJ57141
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1279-13
Product DescriptionPlasma Frozen
Code Info021FJ57141
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1280-13

Class II Biologics Event

Event ID47297
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternIA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info09KG49760; 09KG46759
ClassificationClass II
Reason for RecallBlood products, which were incompletely irradiated, were distributed.
Product Quantity2 units
Recall NumberB-1139-13

Class II Biologics Event

Event ID48041
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternCalifornia and Washington.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info21LL23077.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..
Product Quantity1 component
Recall NumberB-1276-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21LL23077.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..
Product Quantity1 component
Recall NumberB-1277-13
Product DescriptionCryoprecipitated AHF
Code Info21LL23077.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..
Product Quantity1 component
Recall NumberB-1278-13

Class II Drugs Event

Event ID64188
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTG United, Inc.
CityBrooksville
StateFL
CountryUS
Distribution PatternFL, MS, SC, LA and TX
 

Associated Products

Product DescriptionAMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04
Code InfoLot # 12HQ002 Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity1398 - 4 ounce bottles
Recall NumberD-503-2013
Product DescriptionAMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
Code InfoLot # 12DQ002, Exp. 03/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity348 - 16 ounce bottles.
Recall NumberD-504-2013
Product DescriptionAMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16
Code InfoLot # 12DQ005, Exp. 03/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity352 - 16 ounce bottles
Recall NumberD-505-2013
Product DescriptionAMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16
Code InfoLot # 12HQ005, Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity348 - 16 ounce bottles
Recall NumberD-506-2013
Product DescriptionAMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16
Code InfoLot # 12HQ006, Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity348 - 16 ounce bottles
Recall NumberD-507-2013
Product DescriptionAMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.
Code InfoLot # 12HQ007 Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity348 - 16 ounce bottles.
Recall NumberD-508-2013
Product DescriptionAMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
Code InfoLot # 12DQ004, Exp. 03/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity355 - 16 ounce bottles
Recall NumberD-509-2013
Product DescriptionAMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.
Code InfoLot # 12HQ003, Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity348 - 16 ounce bottles
Recall NumberD-510-2013
Product DescriptionAMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
Code InfoLot # 12HQ004, Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity348 - 16 ounce bottles
Recall NumberD-511-2013
Product DescriptionAMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
Code InfoLot # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity1772 bottles per 100 count each
Recall NumberD-512-2013
Product DescriptionAMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
Code InfoLot # 12C007 Exp. 02/14; Lot # 12C008 Exp. 02/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity886 bottles - 100-count tablets
Recall NumberD-513-2013
Product DescriptionRyddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
Code InfoLot # 11E002 Exp. 04/2013.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity2957 bottles 100-count tablets
Recall NumberD-514-2013
Product DescriptionED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
Code InfoLot# 11L008 Exp. 10/13; Lot# 12A001 Exp. 12/13; Lot# 12A002 Exp. 12/13; Lot# 12A006 Exp. 12/13; Lot#12A006 Exp. 12/13; Lot# 12A007 Exp. 12/13; Lot#12D013 Exp. 03/14; Lot# 12F002 Exp. 05/14; Lot# 12H006 Exp.07/14; Lot# 12J001 Exp. 08/14; Lot# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity242,470
Recall NumberD-515-2013
Product DescriptionNoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01
Code InfoLot# 11K010 Exp. 09/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity4824 bottles - 100-count
Recall NumberD-516-2013
Product DescriptionDallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
Code InfoLot# 11L006 Exp. 10/13; Lot# 11L006 Exp. 10/13; Lot# 12B003 Exp 01/14; Lot# 12B003 Exp. 01/14; Lot#12D005 Exp. 03/14; Lot# 12D005 Exp. 03/14; Lot# 12H001 Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity31,739 bottles 100-count; 842,617 Bulk tablet bottles
Recall NumberD-517-2013
Product DescriptionDallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01
Code InfoLot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/2014; Lot# 12F013 Exp. 05/2014.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity8296 bottles - 100-count and 153,028 Bulk tablets
Recall NumberD-518-2013
Product DescriptionBROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
Code InfoLot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/14; Lot# 12F013 Exp. 05/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity22,721 - 16 ounce bottles
Recall NumberD-519-2013
Product DescriptionCardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30
Code InfoLot# 11DQ009 Exp. 03/13; Lot# 11JQ002 Exp. 08/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity26,536 bottles - 30 mL
Recall NumberD-520-2013
Product DescriptionCardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
Code InfoLot# 11CQ001 Exp. 02/13; Lot# 11CQ009 Exp. 02/13; Lot # 11JQ003 Exp. 08/13; Lot# 11JQ004 Exp. 08/23; Lot# 11MQ002 Exp. 11/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity216,838 bottles - 30 mL
Recall NumberD-521-2013
Product DescriptionMaxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
Code InfoLot# 11B002 Exp. 01/13; Lot# 11B003 Exp. 01/13; Lot # 11G007 Exp. 06/13; Lot# 11J002 Exp. 08/13; Lot# 11K002 Exp. 09/13; Lot# 12C011 Exp. 02/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity2706 bottles of 100 count tablets
Recall NumberD-522-2013
Product DescriptionMaxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
Code InfoLot# 11G006 Exp. 06/13; Lot# 11K001 Exp. 09/13; Lot # 11K001 Exp. 09/13; Lot# 12C009 Exp. 02/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity1623 bottles of 100-count tablets.
Recall NumberD-523-2013
Product DescriptionBroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
Code InfoLot# 11A001 Exp. 12/12; Lot# 11L002 Exp. 10/13; Lot # 12K007 Exp. 09/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity10,036 bottles - 100-count tablets
Recall NumberD-524-2013
Product DescriptionBroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
Code InfoLot# 11A002 Exp. 12/12; Lot# 11A003 Exp. 12/12; Lot # 11A004 Exp. 12/12; Lot# 11A005 Exp. 12/12; Lot# 11L003 Exp. 10/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity16,836 bottles - 100-count.
Recall NumberD-525-2013
Product DescriptionBroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
Code InfoLot# 11CQ005 Exp. 02/13; Lot# 11LQ002 Exp. 10/13; Lot # 12CQ005-Exp. 02/14; Lot# 12EQ003 Exp. 04/14; Lot# 12EQ004 Exp. 04/14; Lot# 12JQ004 Exp. 08/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity57,936 bottles - 20 mL and 7,476 bottles -16 ounce
Recall NumberD-526-2013
Product DescriptionBroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
Code InfoLot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/2013.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
Recall NumberD-527-2013
Product DescriptionLusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16
Code InfoLot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 - 19728 20 mL, Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity
Recall NumberD-528-2013
Product DescriptionPoly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
Code InfoLot# 12L005 Exp 10/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity330158 Bulk tablets.
Recall NumberD-529-2013
Product DescriptionPoly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
Code InfoLot# 11F005 Exp 05/13; Lot# 11M008 Exp 11/13; Lot# 12J003 Exp 08/12.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity977,719 Bulk Tablets
Recall NumberD-530-2013
Product DescriptionPoly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
Code InfoLot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002 Exp 08/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity978,092 Bulk Tablets
Recall NumberD-531-2013
Product DescriptionTG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
Code InfoLot# 11A006 Exp 12/12; Lot# 11A007 Exp 12/12; Lot# 11G004 Exp 06/14; Lot# 11G005 Exp 06/14; Lot# 12C004 Exp 02/14; Lot# 12F007 Exp 05/14; Lot# 12F008 Exp.05/14; Lot #12F009 Exp. 05/14; Lot# 12G005 Exp 06/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity386 - 1000-count bottles
Recall NumberD-532-2013
Product DescriptionCPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30
Code InfoLot# 11GQ003 Exp 06/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity6551 30 mL bottles
Recall NumberD-533-2013
Product DescriptionCPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
Code InfoLot# 11EQ007 Exp 04/13; Lot# 12BQ001 Exp. 01/14..
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity26,315 - 30 mL bottles.
Recall NumberD-534-2013
Product DescriptionMesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16
Code InfoLot# 11CQ010 Exp 02/13; Lot# 11EQ003 Exp. 04/13; Lot# 11FQ002 Exp. 05/13; Lot# 11FQ003 Exp. 05/13; Lot# 12HQ009 Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity12,120 - 16 ounce bottles
Recall NumberD-535-2013
Product DescriptionMesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16
Code InfoLot# 11DQ001 Exp 03/13; Lot# 11MQ010 Exp. 11/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity4,884 - 16 ounce bottles
Recall NumberD-536-2013
Product DescriptionTL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
Code InfoLot# 11AQ003 Exp 12/12.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity2532 - 16 ounce bottles.
Recall NumberD-537-2013
Product DescriptionTL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16
Code InfoLot# 11CQ011 Exp 02/13; Lot# 11DQ007 Exp. 03/13; Lot# 11DQ008 Exp. 03/13; Lot# 11EQ002 Exp. 04/13; Lot # 11KQ004 Exp 09/13; Lot# 11KQ005 Exp. 09/13
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity98,202 16 ounce bottles.
Recall NumberD-538-2013
Product DescriptionTL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30
Code InfoLot# 12GQ003 Exp 06/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity13,031 30 mL bottles.
Recall NumberD-539-2013
Product DescriptionTri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
Code InfoLot# 11FQ004 Exp 05/13; Lot# 11KQ001 Exp. 09/13; Lot# 11KQ002 Exp. 09/13; Lot#11KQ003 Exp. 09/13; Lot# 12HQ010 Exp. 07/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity12,198 - 16 ounce bottles.
Recall NumberD-540-2013
Product DescriptionTrigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
Code InfoLot# 11EQ010 Exp 04/13; Lot# 12AQ001 Exp. 12/13; Lot# 12JQ006 Exp. 08/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity39,403 - 30 mL bottles
Recall NumberD-541-2013
Product DescriptionTrigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
Code InfoLot# 11EQ008 Exp 04/13; Lot# 11HQ003 Exp. 07/13; Lot# 12JQ007 Exp. 08/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity40,149 - 30 mL bottles.
Recall NumberD-542-2013
Product DescriptionZ-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30
Code InfoLot# 11DQ004 Exp 03/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity12,988 - 30 mL bottles.
Recall NumberD-543-2013
Product DescriptionZ-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
Code InfoLot# 11EQ004 Exp 04/13.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity2388 - 16 ounce bottles.
Recall NumberD-544-2013
Product DescriptionZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
Code InfoLot# 11EQ009 Exp 04/13; Lot# 12AQ004 Exp. 12/13; Lot# 12KQ001 Exp. 09/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity39,801 - 30 mL bottles.
Recall NumberD-545-2013
Product DescriptionZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
Code InfoLot# 11CQ012 Exp 02/13; Lot# 12GQ002 Exp. 06/14.
ClassificationClass II
Reason for RecallCGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Quantity4811 - 16 ounce bottles.
Recall NumberD-546-2013

Class II Biologics Event

Event ID64377
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifesouth Community Blood Centers, Inc. - Mobile Region
CityMobile
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112335533G;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-1272-13

Class II Biologics Event

Event ID64378
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW1151130013868;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-1273-13

Class II Biologics Event

Event ID64432
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South FL, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036810231777;
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1104-13

Class II Biologics Event

Event ID64450
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUpstate New York Transplant Services
CityBuffalo
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW280312001390;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1441-13
Product DescriptionCryoprecipitated AHF
Code InfoW280312001390;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1442-13

Class II Biologics Event

Event ID64451
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1151130020407;
ClassificationClass II
Reason for RecallBlood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
Product Quantity1
Recall NumberB-1017-13

Class II Biologics Event

Event ID64472
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUpstate New York Transplant Services
CityBuffalo
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW28031280552;
ClassificationClass II
Reason for RecallBlood product, with platelet yield below the specified minimum requirement, was distributed.
Product Quantity1
Recall NumberB-1474-13

Class II Biologics Event

Event ID64473
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmNew York Blood Center, Inc.
CityNew Brunswick
StateNJ
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW0470123710240; W0470123710240; (double unit)
ClassificationClass II
Reason for RecallBlood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.
Product Quantity2
Recall NumberB-1473-13

Class II Biologics Event

Event ID64475
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals LLC
CityStillwater
StateOK
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code InfoST1068311; ST1068692; ST1068971; ST1070131; ST1070344; ST1070813; ST1071082; ST1072200; ST1072433; ST1072809; ST1073309; ST1073493; ST1074119; ST1074203; ST1074732; ST1067724; ST1067959;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had not had an annual physical performed, were distributed.
Product Quantity17
Recall NumberB-1472-13

Class II Biologics Event

Event ID64484
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW043209019747;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1382-13
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW043209019747;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1383-13

Class II Biologics Event

Event ID64488
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDept Of The Navy, Naval Medical Center
CityPortsmouth
StateVA
CountryUS
Distribution PatternVirginia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW021512002231;
ClassificationClass II
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1360-13

Class II Biologics Event

Event ID64489
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDept Of The Navy, Naval Medical Center
CityPortsmouth
StateVA
CountryUS
Distribution PatternVirginia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW021512001845; W021512004439;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1361-13

Class II Biologics Event

Event ID64491
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest Tennessee Regional Blood Center Inc
CityJackson
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW040812117735;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1362-13

Class II Biologics Event

Event ID64492
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDept Of The Navy, Naval Medical Center
CityPortsmouth
StateVA
CountryUS
Distribution PatternNew Jersey
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW021512004565;
ClassificationClass II
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1363-13

Class II Biologics Event

Event ID64517
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternNebraska
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW044113003135;
ClassificationClass II
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1356-13

Class II Biologics Event

Event ID64518
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa; South Carolina
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW044112128378 Part 1; W044112128378 Part 2;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity2
Recall NumberB-1357-13

Class II Biologics Event

Event ID64520
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInova Health Care Services, Inova Blood Donor Services
CitySterling
StateVA
CountryUS
Distribution PatternNew York; Indiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW089811607217;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1358-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW089811607217;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1359-13

Class II Biologics Event

Event ID64523
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems Inc
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW041013005157E; W041013005157E
ClassificationClass II
Reason for RecallBlood Products, collected from an ineligible donor, were distributed.
Product Quantity2 units
Recall NumberB-1483-13

Class II Devices Event

Event ID64550
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHill-Rom, Inc.
CityBatesville
StateIN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.
 

Associated Products

Product DescriptionSlingBar 350. Designed to meet the needs for lifting humans.
Code Info3156015, 3156002, 3156008' 3156004
ClassificationClass II
Reason for RecallRetrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.
Product Quantity3556
Recall NumberZ-1473-2013
Product DescriptionSlingBar 360. Designed to meet the needs for lifting humans.
Code InfoProduct # 3156013
ClassificationClass II
Reason for RecallRetrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.
Product Quantity16
Recall NumberZ-1474-2013
Product DescriptionSlingBar Wide 670. Designed to meet the needs for lifting humans.
Code InfoProduct # 3156012, 3156017
ClassificationClass II
Reason for RecallRetrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.
Product Quantity412
Recall NumberZ-1475-2013
Product DescriptionSlingBar Standard. Designed to meet the needs for lifting humans.
Code InfoProduct #3156011
ClassificationClass II
Reason for RecallRetrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.
Product Quantity726
Recall NumberZ-1476-2013

Class II Biologics Event

Event ID64573
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmRhode Island Blood Center
CityProvidence
StateRI
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW051712639896;
ClassificationClass II
Reason for RecallBlood product, collected from a donor with risk factors for vCJD, was distributed.
Product Quantity1 product
Recall NumberB-1475-13

Class II Biologics Event

Event ID64627
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2320628
ClassificationClass II
Reason for RecallBlood products, collected from an inelgible donor, were distributed.
Product Quantity1 unit
Recall NumberB-1484-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info2476618; 2476618
ClassificationClass II
Reason for RecallBlood products, collected from an inelgible donor, were distributed.
Product Quantity2 units
Recall NumberB-1485-13

Class II Drugs Event

Event ID64635
StatusTerminated
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPetnet Solution Inc
CityIrvine
StateCA
CountryUS
Distribution PatternWithin the state of CA.
 

Associated Products

Product DescriptionFludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
Code InfoBatch # BN-3350 Rx #s: [38126044] [38126058] [38126059] [38126021] [38126022] [38126023] [38125981] [38125991] [38125992] [38126016] [38126017] [38126004] [38126005] [38126006] [38126007] [38126057] [38125999] [38126036] [38126037] [38126038] [38125998] [38126033]
ClassificationClass II
Reason for RecallcGMP Deviation
Product Quantity28 doses
Recall NumberD-579-2013

Class II Devices Event

Event ID64803
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmShimadzu Medical Systems
CityTorrance
StateCA
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionShimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
Code InfoIn combination with CXDI-70C: Serial Numbers: 410001F0A004 410001B13012 410001B13016 410001F0A005 410001B1300E 410001B13010 0162S67303 410001B13018 410001B1300A 410001B13017 410001B1301B 410001B1301A 410001B13019 410001B1301D 410001B13011 410001B1301C 410001B13001 410001B13015 410001F0B004 410001B13008 410001B13013 410001F0B005 410001F0B006 410001F0A007 410001B13009 410001B1300B 410001B15035 410001B13014 410001B14009 410001B1301F 410001B14002 410001B14001 410001B14006 410001B14004 410001B15005 410001B13002 410001B1301E 410001B15016 410001B15009 410001B15007 410001B15006 410001B1300F 410001B15001 410001B15017 410001B15002 410001B15020 In combination with CXDI-55C: Serial Numbers: 0162S65805 0162S65810 0162S65808 0162S66001 0162S66008 0162S65809 0162S66004 0162S66005 0162S66009 0162S66010 0162S66201 0162S66202 0162S66207 0162S66208 0162S66206 0162S66302 0162S66402 0162S66409 0162S66410 0162S66403 0162S66501 0162S66405 0162S66407 0162S66406 0162S66505 0162S66502 0162S66503 0162S66408 0162S66504 0162S66603 0162S66508 0162S66507 0162S66510 0162S66709 0162S66601 0162S66610 0162S66609 0162S66605 In combination with CXDI-55G Serial Numbers: 0162S66205 0162S66307 0162S66309 0162S65901 0162S66003 0162S66306 0162S66308 0162S66509 0162S65709 0162S66606 0162S66802 0162S66803
ClassificationClass II
Reason for RecallThe recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.
Product Quantity103 units
Recall NumberZ-1369-2013

Class II Devices Event

Event ID64826
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmI-Flow LLC
CityLake Forest
StateCA
CountryUS
Distribution PatternNationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
 

Associated Products

Product DescriptionI-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Code InfoLot # AW207202O
ClassificationClass II
Reason for RecallI-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
Product Quantity450 units
Recall NumberZ-1444-2013
Product DescriptionI-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Code InfoLot # AW207202U
ClassificationClass II
Reason for RecallI-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
Product Quantity75 units
Recall NumberZ-1445-2013

Class II Food Event

Event ID64831
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmChemi- Source Inc, Nutra Pak
CityGrand Rapids
StateMI
CountryUS
Distribution Patternnationwide
 

Associated Products

Product DescriptionAll Natural Whey - Natural Flavor 1.89 LBS: Whey Protein Concentrate and Isolate, Casein/Caseinate, Nitrozyme UPC 6-09492 72000-9 :
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity 24924
Recall NumberF-1478-2013
Product DescriptionIsolate Whey Protein Chocolate Malt 2.03 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Cocoa, Xylitol ; UPC 6-09492 73010-7
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity10,860
Recall NumberF-1479-2013
Product DescriptionIsolate Whey Protein French Vanilla 1.99 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Xylitol UPC 6-09492 73011-4
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity12,431
Recall NumberF-1480-2013
Product DescriptionLow Carb Protein - Strawberry/Banana 1.78 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate,Soy Lecithin, Red Beet Powder UPC 6-09492 72018-4
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity7,441
Recall NumberF-1481-2013
Product DescriptionMetabolic Whey - Straw/Banana 5 LBS & 10 LBS: Whey Protein Concentrate/ Isolate, UPC 6-09492 72052-8, 72055-9
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk and source of lecithin not listed as soy. Milk and soy are allergens. Consumers who have an allergy or severe sensitivity to milk, soy run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity5# x 12,925; 10 # x 2,054
Recall NumberF-1482-2013
Product DescriptionUPC6-09492 72050-4, 72053-5 , Metabolic Whey - Rich Chocolate 5 LBS, 10 LBS : Whey Protein Concentrate/ Isolate, Cocoa
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk and source of lecithin ingredient not listed as soy, Milk and soy are allergens. Consumers who have an allergy or severe sensitivity to milk, soy run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity5 # x 34,409; 10# x 7,983
Recall NumberF-1483-2013
Product DescriptionIt Works Ultimate Profit Chocolate 1.6 LBS: Whey Protein Concentrate/ Isolate, Soy Protein Extract, Soy Hull Fiber; Soy Protein Isolate; Contains: Dairy, Cocoa
Code Info: Product distributed with expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity74409
Recall NumberF-1484-2013
Product DescriptionIt Works Ultimate Profit Vanilla 1.55 LBS: Whey Protein Concentrate/ Isolate, Soy Protein, Soy Hull Flower Contains: Dairy
Code InfoProduct distributed with expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity69519
Recall NumberF-1485-2013
Product DescriptionCasein - 100% Micellar Casein - Rich Chocolate 2.02 LBS: Soy Lecithin,Casein/Caseinate, Cocoa UPC 6-09492 72240-9
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity2932
Recall NumberF-1486-2013
Product DescriptionCasein - 100% Micellar Casein - Cookies & Cream 2.02 LBS: Soy Lecithin,Casein/Caseinate,Wheat UPC 6-09492 72242-3
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity1,320
Recall NumberF-1487-2013
Product DescriptionCasein - 100% Micellar Casein - Vanilla Ice Cream 2.04 LBS: Soy Lecithin,Casein/Caseinate UPC 6-09492 72241-6
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity1,182
Recall NumberF-1488-2013
Product DescriptionMassive Muscle Gainer- Weight Gainer  French Vanilla 10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity3,227
Recall NumberF-1489-2013
Product DescriptionLow Carb Protein- French Vanilla 1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 72016-0
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product QuantityUPC 6-09492 72016-0
Recall NumberF-1490-2013
Product DescriptionAll Natural Gainer- Rich Vanilla 3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity19,338
Recall NumberF-1491-2013
Product DescriptionLow Carb Protein  -  Creamy Chocolate 1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 72017-7
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity22,712
Recall NumberF-1492-2013
Product DescriptionAll Natural Gainer - Chocolate 3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73004-6
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity16,318
Recall NumberF-1493-2013
Product DescriptionMassive Muscle Gainer- Weight Gainer  Dutch Chocolate 10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73002-2
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity14,813
Recall NumberF-1494-2013
Product DescriptionMetabolic Whey - Vanilla 5 LBS French Vanilla 10lbs: Whey Protein/Isolate, Soy Lecithin UPC 6-09492 72051-1 (VANILLA) UPC 6-09492 72054-2 (FRENCH VANILLA)
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen; soy lecithin stated as "lecithin".Consumers who have an allergy or severe sensitivity to milk or soy run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity5 # x 34,409 ; 10 # x 12,925
Recall NumberF-1495-2013
Product DescriptionFruit-N-Whey 2.03lbs and Fruit-N-Whey Mixed Berries 2.03 lbs: Whey Protein/Isolate, Soy Lecithin. Contains: Dairy, Benefruit Blend, Natural Berry Flavors UPC 6-09492 72065-8
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity5047
Recall NumberF-1496-2013
Product DescriptionFlax-N-Whey and Flax-N-Whey Vanilla Nut 1.99 lbs: Whey Protein/Isolate Contains: Soy, Dairy, Flaxseed UPC 6-09492 72064-1
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity4072
Recall NumberF-1497-2013
Product DescriptionMRM All Natural Whey - Dutch Chocolate 2.02 lbs, 1.01 lbs; All Natural Whey 10pk/bx Dutch Chocolate: Whey Protein/Isolate Contains: Soy, Dairy, Cocoa, Nitrozyme UPC 6-09492 72004-7 (2.02 lbs) UPC 6-09492 72095-5 (10 pk) UPC 6-09492 72005-4(1.01 lbs)
Code Info expiration date between Jan 2013 and March 2016. ;
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity2.02 # x 136726; 1.01 # x 49,235; 10 pak x 42,699
Recall NumberF-1498-2013
Product DescriptionAll Natural Whey - Rich Vanilla: 2.02 lbs, 1.01 lbs and 10pk/bx : Whey Protein/Isolate Contains: Soy, Dairy, Nitrozyme UPC 6-09492 72002-3 (2.02 lbs) UPC 6-09492 72006-1 (1.01 lbs) UPC 6-09492 72094-8 (10 pk)
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity2.02# x 187,888; 1.01#x 80,085; 10 pk x 13, 578
Recall NumberF-1499-2013
Product DescriptionSprouts Farmers Market Whey Protein Vanilla: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68118-9 (1 lbs) UPC 6-46670 68124-0 (2 lbs)
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity1 # x 16,010; 2 # x 12,727
Recall NumberF-1500-2013
Product DescriptionSprouts Farmers Market Whey Protein Chocolate: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68120-2 (1 lbs) UPC 6-46670 68126-4 (2 lbs)
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity1 # x 5,872; 2# x 7,798
Recall NumberF-1501-2013
Product DescriptionSprouts Farmers Market Whey Protein Strawberry: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68122-6 (1 lbs) UPC 6-46670 68128-8 (2 lbs):
Code Infoexpiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity1 lb x 4,946; 2 lb x 4715
Recall NumberF-1502-2013
Product DescriptionDelicious Whole-istic Whey Protein Duch Chocolate 1.6 lbs: Whey Protein/Isolate, Contains: Dairy, Soy Lecithin UPC8-54809 0030-9
Code Info expiration date between Jan 2013 and March 2016.
ClassificationClass II
Reason for RecallSource of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Product Quantity0 , corrected in warehouse
Recall NumberF-1503-2013

Class II Devices Event

Event ID64927
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmKreg Medical Inc.
CityChicago
StateIL
CountryUS
Distribution PatternNationwide Distribution including IL and IN.
 

Associated Products

Product DescriptionE-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
Code InfoModels ASM100100 and ASM100104; Lot 1 (Blue Beds) Serian Numbers: KM100101, KM100102, KM100103, KM100104, KM100105, KM100106, KM100107, KM100108, KM100209, KM100100; Lot 2 (White Beds) Serial Numbers: KM100109, KM100111, KM100112, KM100113, KM100114, KM100115, KM100116, KM100117, KM100118, KM100119, KM100120; Lot 3 (White Beds) Serial Numbers: KM100144, KM100145, KM100146, KM100147, KM100148, KM100149, KM100150, KM100151, KM100152, KM100153, KM100154, KM100155, KM100156, KM100156, KM100157, KM1000158; Lot 4: (White Beds) Serial Numbers: KM100194, KM100195, KM100196, KM100197, KM100198, KM100199, KM100200, KM100201, KM100202, KM100203, KM100204, KM100205, KM100206, KM100207, KM100208; Lot 5: (White Beds) Serial Numbers: KM100211, KM100212, KM100213, KM100214, KM100215, KM100216, KM100217, KM100218
ClassificationClass II
Reason for RecallAn EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.
Product Quantity59 beds
Recall NumberZ-1480-2013

Class II Devices Event

Event ID64968
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLeica Microsystems, Inc.
CityBuffalo Grove
StateIL
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
 

Associated Products

Product DescriptionLPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
Code Info1) Part No.: 14060546848; Batch No.s: 8280-10309, 82801-0310; 2) Part No.: 14060546846; Batch No.s: 1034710114; 3) Part No.: 14060546845; Batch No.s: 1021420914; 4) Part No.: 14060546933; Batch No.s: 82801-0217; 5) Part No.: 14060546932; Batch No.s: 1030730112, 1101110204; 6) Part No.: 14060546852; Batch No.s: 1101910322; 7) Part No.: 14060546850; Batch No.s: 1034710204, 1034710328, 1113910803; 8) Part No.: 14060546847; Batch No.s: 913920827
ClassificationClass II
Reason for RecallAn LPC Fine Mesh Cassette failed to stay closed during processing operations.
Product Quantity20,160 units
Recall NumberZ-1446-2013

Class II Devices Event

Event ID64991
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
 

Associated Products

Product DescriptionStraight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Code InfoLot number: 20856
ClassificationClass II
Reason for RecallDuring two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Product Quantity10
Recall NumberZ-1482-2013

Class II Devices Event

Event ID65006
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlcon Grieshaber AG
CitySchaffhausen
State
CountryCH
Distribution PatternWorldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turknenistan, Venezula, and Viet Nam.
 

Associated Products

Product DescriptionThe Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
Code InfoAll Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01
ClassificationClass II
Reason for RecallAlcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.
Product Quantity8,455 units
Recall NumberZ-1506-2013

Class II Devices Event

Event ID65062
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBerchtold Corp.
CityN Charleston
StateSC
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionHand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Code InfoThe hand controls are neither serialized nor lot coded.
ClassificationClass II
Reason for RecallThe firm received complaints for unintended movements.
Product Quantity3763
Recall NumberZ-1488-2013

Class II Devices Event

Event ID65093
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCovidien LP
CityNorth Haven
StateCT
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
 

Associated Products

Product DescriptionVersaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Code InfoLot Numbers: N2H0414X through N3A0294X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
ClassificationClass II
Reason for RecallSeals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Product Quantity2716 units
Recall NumberZ-1467-2013
Product DescriptionVersaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Code InfoLot Numbers: N2h0413X through N3A0391X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
ClassificationClass II
Reason for RecallSeals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Product Quantity23050 units
Recall NumberZ-1468-2013
Product DescriptionVersaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Code InfoLot Numbers: N2H0353X through N3D0033X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
ClassificationClass II
Reason for RecallSeals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Product Quantity126925 units
Recall NumberZ-1469-2013
Product DescriptionVersaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Code InfoLot Numbers: N2J0211X through N3D0118X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
ClassificationClass II
Reason for RecallSeals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Product Quantity5364 units
Recall NumberZ-1470-2013
Product DescriptionVersaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Code InfoLot Numbers: N2J0315X through N3A0389X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
ClassificationClass II
Reason for RecallSeals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Product Quantity2705 units
Recall NumberZ-1471-2013
Product DescriptionVersaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Code InfoLot Numbers: N2J0150X through N3C0683X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
ClassificationClass II
Reason for RecallSeals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Product Quantity57461 untis
Recall NumberZ-1472-2013

Class II Devices Event

Event ID65098
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Optisurgical Inc
CityLake Forest
StateCA
CountryUS
Distribution PatternNationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.
 

Associated Products

Product DescriptionFAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Code InfoLot Numbers 07912-06 12912-04
ClassificationClass II
Reason for RecallAmerican Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.
Product Quantity63 individual applicators
Recall NumberZ-1505-2013

Class II Food Event

Event ID65106
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNestle USA, Inc - Northbrook Pizza Head Office
CityNorthbrook
StateIL
CountryUS
Distribution PatternUS nationwide distribution only. NO OUS.
 

Associated Products

Product DescriptionDiGiorno pizzeria, bianca/white pizza , Net Wt.18.0 OZ (510 g), UPC 71921-91484
Code InfoProduction code: 3068525951
ClassificationClass II
Reason for RecallPlastic contamination. Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic
Product Quantity5,958 cases (10 pizzas/case)
Recall NumberF-1468-2013
Product Descriptioncalifornia Pizza Kitchen crispy thin crust, White, Crispy thin crust pizza topped with garlic creme fraiche sauce, spinach, garlic, mozzarella,cheeses, parmesan, asiago and romano cheeses. Net Wt.12.8 OZ (363 g), UPC 71921-98745
Code InfoProduction codes: 3062525951, 3062525952. and 3063525951
ClassificationClass II
Reason for RecallPlastic contamination. Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic
Product Quantity16,163 cases (14 pizzas/case)
Recall NumberF1467-2013

Class II Devices Event

Event ID65109
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarl Zeiss Meditec, Inc.
CityDublin
StateCA
CountryUS
Distribution PatternUS Nationwide Distribution.
 

Associated Products

Product DescriptionZeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
Code InfoSerial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813
ClassificationClass II
Reason for RecallCarl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.
Product Quantity6 units
Recall NumberZ-1440-2013

Class II Devices Event

Event ID65113
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Optisurgical Inc
CityLake Forest
StateCA
CountryUS
Distribution PatternWorldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.
 

Associated Products

Product DescriptionAmerican Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Code InfoSerial#: 5510124 55400000 55400001 55400002 55400003 55400004 55400005 55400006 55400007 55400008 55400009 55400010 55400011 55400012 55400013 55400014 55400015 55400016 55400017 55400018 55400019 55400020 55400021 55400022 55400023 55400024 55400025 55400026 55400027 55400028 55400029 55400030 55400031 55400032 55400033 55400034 55400035 55400036 55400037 55400038 55400039 55400040 55400041 55400042 55400043 55400044 55400045 55400046 55400047 55400048 55400049 55400050 55400051 55400052 55400053 55400054 55400055 55400056 55400057 55400058 55400059 55400060 55400061 55400062 55400063 55400064 55400065 55400066 55400067 55400068 55400069 55400070 55400071 55400072 55400073 55400074 55400075 55400076 55400077 55400078 55400079 55400080 55400081 55400082 55400083 55400084 55400085 55400086 55400087 55400088 55400089 55400090 55400091 55400092 55400093 55400094 55400095 55400096 55400097 55400098 55400099 55400100 55400101 55400102 55400103 55400104 55400105 55400106 55400107 55400108 55400109 55400110 55400111 55400112 55400113 55400114 55400115 55400116 55400117 55400118 55400119 55400120 55400121 55400122 55400123 55400124 55400125 55400126 55400127 55400128 55400129 55400130 55400131 55400132 55400133 55400134 55400135 55400136 55400137 55400138 55400139 55400140 55400141 55400142 55400143 55400144 55400145 55400146 55400147 55400148 55400149 55400150 55400151 55400152 55400153 55400154 55400155 55400156 55400157 55400158 55400159 55400160 55400161 55400162 55400163 55400164 55400165 55400166 55400167 55400168 55400169 55400170 55400171 55400172 55400173 55400174 55400175 55400176 55400177 55400178 55400179 55400180 55400181 55400182 55400183 55400184 55400185 55400186 55400187 55400188 55400189 55400190 55400191 55400192 55400193 55400194 55400195 55400196 55400197 55400198 55400199 55400200 55400201 55400202 55400203 55400204
ClassificationClass II
Reason for RecallThe recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop working.
Product Quantity194 units
Recall NumberZ-1516-2013

Class II Drugs Event

Event ID65125
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTHE COMPOUNDING SHOP, INC.
CitySt Petersburg
StateFL
CountryUS
Distribution PatternFlorida, California, Minnesota, and Maine
 

Associated Products

Product DescriptionMethotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity19 vials of 10ml
Recall NumberD-548-2013
Product DescriptionAvastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity80 vials of 4mL each
Recall NumberD-549-2013
Product DescriptionBaclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity1 vial of 22mL
Recall NumberD-550-2013
Product DescriptionBaclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity1 vial of 20mL and 1 vial of 40mL
Recall NumberD-551-2013
Product DescriptionBaclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity3 vials of 45mL
Recall NumberD-552-2013
Product DescriptionBetamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity20 vials of 5mL
Recall NumberD-553-2013
Product DescriptionDexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity2 vials of 100mL
Recall NumberD-554-2013
Product DescriptionDexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity41 vials of 2mL
Recall NumberD-555-2013
Product DescriptionHydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL
Recall NumberD-556-2013
Product DescriptionSodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity43 vials of 250mL each
Recall NumberD-557-2013
Product DescriptionGlutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity7 vials of 50mL each
Recall NumberD-558-2013
Product DescriptionLipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity55 vials of 100mL
Recall NumberD-559-2013
Product DescriptionMitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity4 vials of 10mL each
Recall NumberD-560-2013
Product DescriptionMethylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity44 vials of 50mL each
Recall NumberD-561-2013
Product DescriptionProcaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity2 vials of 250mL and 26 vials of 100mL
Recall NumberD-562-2013
Product DescriptionAscorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity78 vials of 500ml and 92 vials of 100mL
Recall NumberD-563-2013
Product DescriptionB-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity56 vials of 50mL
Recall NumberD-564-2013
Product DescriptionPhosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity32 vials of 50mL
Recall NumberD-565-2013
Product DescriptionMIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity14 vials of 30mL each
Recall NumberD-566-2013
Product DescriptionTestosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL
Recall NumberD-567-2013
Product DescriptionMorphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity1 vial of 40mL
Recall NumberD-568-2013
Product DescriptionCarnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity1 vial of 40ml
Recall NumberD-569-2013
Product DescriptionPraziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity5 vials of 50mL
Recall NumberD-570-2013
Product DescriptionMIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity10 vials of 30 mL each
Recall NumberD-571-2013
Product DescriptionTri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
Code InfoAll Lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity4 vials of 5mL and 22 vials of 10mL
Recall NumberD-572-2013

Class II Devices Event

Event ID65140
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV & WY. Internationally to Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, India, Indonesia, Iran, Italy, Japan, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Syria, Thailand, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Venezuela & Viet Nam.
 

Associated Products

Product DescriptionBrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
Code InfoModel # 882480, Serial #'s: 400054,400381, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000098, 4000099, 4000100, 4000102, 4000103, 4000104, 4000105, 4000106, 4000107, 4000108, 4000109, 4000110, 4000111, 4000112, 4000113, 4000114, 4000115, 4000116, 4000117, 4000118, 4000119, 4000120,4000121, 4000122, 4000123, 4000124, 4000125, 4000126, 4000127, 4000128, 4000129, 4000130, 4000132, 4000133, 4000135, 4000136, 4000137, 4000138, 4000139, 4000140, 4000141, 4000142, 4000143, 4000144, 4000145, 4000146, 4000148, 4000149, 4000151, 4000152, 4000153, 4000154, 4000155, 4000156, 4000157, 4000158, 4000159, 4000160, 4000161, 4000162, 4000164, 4000165, 4000166, 4000167, 4000168, 4000169, 4000170, 4000171, 4000173, 4000174, 4000175, 4000176, 4000177, 4000178, 4000179, 4000180, 4000181, 4000182, 4000183, 4000184, 4000185, 4000186, 4000187, 4000188, 4000189, 4000190, 4000191, 4000192, 4000193, 4000194, 4000195, 4000196, 4000197, 4000198, 4000200, 4000202, 4000203, 4000204, 4000205, 4000206, 4000207, 4000208, 4000209, 4000212, 4000214, 4000215, 4000216, 4000218, 4000219, 4000220, 4000221, 4000222, 4000223, 4000224, 4000225, 4000226, 4000227, 4000228, 4000229, 4000230, 4000231, 4000232, 4000233, 4000234, 4000235, 4000236, 4000237, 4000238, 4000239, 4000240, 4000241, 4000242, 4000243, 4000244, 4000245, 4000246, 4000247, 4000248, 4000249, 4000250, 4000251, 4000252, 4000253, 4000254, 4000255, 4000256, 4000257, 4000258, 4000259, 4000260, 4000261, 4000262, 4000263, 4000264, 4000265, 4000266, 4000267, 4000268, 4000269, 4000270, 4000271, 4000272, 4000273, 4000274, 4000275, 4000276, 4000277, 4000278,4000279, 4000280, 4000282, 4000283, 4000284, 4000285, 4000287, 4000289, 4000290, 4000291, 4000292, 4000293, 4000295, 4000296, 4000297, 4000298, 4000300, 4000301, 4000302, 4000303, 4000304, 4000305, 4000306, 4000307, 4000308, 4000309, 4000310, 4000311, 4000312, 4000313, 4000314, 4000315, 4000316, 4000317, 4000318, 4000319, 4000320, 4000321, 4000322, 4000323, 4000324, 4000325, 4000326, 4000327, 4000328, 4000329, 4000330, 4000331, 4000332, 4000333, 4000334, 4000335, 4000336, 4000337, 4000338, 4000339, 4000340, 4000341, 4000342, 4000343, 4000344, 4000345, 4000346, 4000347, 4000348, 4000349, 4000351, 4000352, 4000353, 4000354, 4000355, 4000356, 4000357, 4000358, 4000359, 4000360, 4000361, 4000362, 4000363, 4000364, 4000365, 4000366, 4000367, 4000368, 4000369, 4000370, 4000371, 4000372, 4000374, 4000375, 4000376, 4000377, 4000378, 4000379, 4000380, 4000381, 4000382, 4000383, 4000384, 4000385, 4000386, 4000387, 4000388, 4000389, 4000390, 4000391, 4000392, 4000394, 4000396, 4000397, 4000398, 4000399, 4000400, 4000401, 4000402, 4000403, 4000404, 4000405, 4000406, 4000407, 4000408, 4000410, 4000411, 4000412, 4000414, 4000415, 4000416, 4000417, 4000418, 4000419, 4000420, 4000421, 4000422, 4000423, 4000424, 4000425, 4000426, 4000428, 4000429, 4000430, 4000431, 4000432, 4000433, 4000434, 4000435, 4000436, 4000437, 4000438, 4000439, 4000440, 4000441, 4000442, 4000443, 4000444, 4000445, 4000446, 4000447, 4000448, 4000449, 4000450, 4000451, 4000452, 4000453, 4000454, 4000455, 4000456, 4000459, 4000460, 4000461, 4000462, 4000463, 4000464, 4000466, 4000467, 4000468, 4000469, 4000470, 4000473, 4000474, 4000475, 4000476, 4000478, 4000479, 4000480, 4000481, 4000482, 4000483, 4000485, 4000485, 4000486, 4000487, 4000488, 4000489, 4000490, 4000491, 4000492, 4000493, 4000494, 4000495, 4000496, 4000497, 4000498, 4000499, 4000500, 4000501, 4000502, 4000503, 4000504, 4000505, 4000506, 4000507, 4000508, 4000509, 4000510, 4000511, 4000513, 4000516, 4000517, 4000518, 4000519, 4000520, 4000521, 4000522, 4000523, 4000524, 4000525, 4000526, 4000527, 4000527, 4000528, 4000529, 4000530, 4000531, 4000532, 4000533, 4000534, 4000535, 4000536, 4000537, 4000538, 4000539, 4000540, 4000541,4000542, 4000543, 4000544, 4000546, 4000547, 4000549, 4000550, 4000551, 4000552, 4000553, 4000554, 4000555, 4000556, 4000557, 4000558, 4000559, 4000560, 4000561, 4000562, 4000563, 4000564, 4000565, 4000566, 4000567, 4000568, 4000569, 4000571, 4000572, 4000573, 4000574, 4000575, 4000576, 4000577, 4000578, 4000580, 4000581, 4000582, 4000583, 4000584, 4000585, 4000586, 4000587, 4000588, 4000590, 4000591, 4000592, 4000593, 4000594, 4000595, 4000596, 4000597, 4000598, 4000600, 4000601, 4000602, 4000603, 4000604, 4000605, 4000606, 4000607, 4000609, 4000610, 4000611, 4000614, 4000614, 4000616, 4000620, 4000621, 4000623, 4000636, 4340004, 40000092, 0000101, 41443714, 49544434, 4000703001, 40007050005, 40007060007, 40007060008, 4000098A, 4000103-4000151-1,4000223-1, 4000246A, 4000301-1, 4000472A & 4000484A.
ClassificationClass II
Reason for RecallPhilips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.
Product Quantity505 units
Recall NumberZ-1481-2013

Class II Devices Event

Event ID65160
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaytex Corp
CityHayward
StateCA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI; and country of: Mexico.
 

Associated Products

Product DescriptionComfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.
Code InfoAll cases of item #: 3100 face mask with PO #. PO #, Date of receipt: 809-01, 2/5/08; 837-02, 7/29/08; 852-03, 10/10/08; 901-01, 2/3/09; 921-02, 6/8/09; 923-03, 7/8/09; 926-04, 8/26/09; 931-05, 11/10/09; 942-06, 12/16/09; 001-01, 2/17/10; 003-03, 4/12/10; 002-02 , 3/24/10; 003-03A, 7/23/10; 042-04, 11/29/10; 105-01, 1/31/11; 117-02, 4/29/11; 127/03, 7/8/11; 147-04, 12/16/11; 202-01, 3/8/2012; 224-02, 5/24/2012; 235-03, 9/12/2012; 253-04 , 12//192012
ClassificationClass II
Reason for RecallRecent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant.
Product Quantity43,915 Cases
Recall NumberZ-1451-2013

Class II Devices Event

Event ID65164
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.
 

Associated Products

Product DescriptionCanister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
Code InfoCanisters with date code of 02-2013 (Feb 2013)
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.
Product Quantity800
Recall NumberZ-1443-2013

Class II Devices Event

Event ID65168
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
 

Associated Products

Product Descriptionda Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
Code InfoModel number 420011
ClassificationClass II
Reason for RecallIntuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
Product Quantity2101 consignees
Recall NumberZ-1463-2013
Product Descriptionda Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
Code InfoModel number 420262
ClassificationClass II
Reason for RecallIntuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
Product Quantity2101 consignees
Recall NumberZ-1464-2013

Class II Food Event

Event ID65174
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSmiling Hill Farm, Inc. dba Silvery Moon Creamery
CityWestbrook
StateME
CountryUS
Distribution PatternME, NH, CT
 

Associated Products

Product DescriptionSmiling Hill Farm brand Butter, 1/2 lb, 5 lb; Unlabeled: 1/2 lb, 5 lb, 30-40 lb (variable in 5 gallon buckets) Product in plastic snap-lid containers.
Code InfoE4-11, E5-11, E6-11, A1-12, A2-12, A3-12, A4-12, A5-12, A6-12, A7-12, A8-12, A9-12, A10-12, A11-12, A12-12, B1-12, B2-12, B3-12, B4-12, B5-12, B6-12, B7-12, B8-12, B9-12, B10-12, B11-12, B12-12, C1-12, C2-12, C3-12, C4-12, C5-12, C6-12, C7-12, C8-12, C9-12, C10-12, C11-12, C12-12, D1-12, D2-12, D3-12, D4-12, D5-12, D6-12, D7-12, D8-12, D9-12, D10-12, D11-12, D12-12, E1-12, E2-12, E3-12, E4-12, E5-12, E6-12, E7-12, E8-12, E9-12, E10-12, E11-12, E12-12, F1-12, F2-12, F3-12, F4-12, F5-12, F6-12, F7-12, F8-12, F9-12, A1-13, A2-13, A3-13, A4-13, A5-13, A6-13, A7-13, A8-13, A9-13, A10-13, A11-13, A12-13, B1-13, B2-13, B3-13, B4-13, B5-13, B6-13, B7-13, B8-13, B9-13, B10-13, B11-13, B12-13, C1-13
ClassificationClass II
Reason for RecallElevated standard plate counts and detectable coliform bacteria.
Product Quantity9046 pounds
Recall NumberF-1477-2013

Class II Drugs Event

Event ID65180
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPentec Health
CityBoothwyn
StatePA
CountryUS
Distribution PatternDialysis Centers Direct to patient
 

Associated Products

Product DescriptionProplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
Code InfoCompounding Date: 4/25/13 Discard after: 5/16/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity1 Bag
Recall NumberD-581-2013
Product DescriptionBaxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Code InfoDate: 04/30/13 Discard After: 05/21/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity3 units
Recall NumberD-582-2013
Product DescriptionBaxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Code Infoa) Compounding Date: 04/30/13 Discard After: 05/21/13 b) Compounding Date: 04/30/13 Discard After: 05/21/13 c) Compounding Date: 04/25/13, 04/30/13 Discard After: 05/16/13, 05/21/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity5 Bags
Recall NumberD-583-2013
Product DescriptionFresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/30/13 Discard after: 05/21/13
ClassificationClass II
Reason for RecallSterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity1 Bag
Recall NumberD-584-2013
Product DescriptionIDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Code InfoCompounding Date: a) 04/25/13, b) 04/24/13 Discard After: a) 05/20/13, b) and c) 05/15/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity3 Bags
Recall NumberD-585-2013
Product DescriptionProplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/24/13 Discard after: 05/15/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity9 Bags
Recall NumberD-586-2013
Product DescriptionProplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/24/13, 04/25/13, 04/29/13 Discard after: 05/15/13, 05/16/13, 05/20/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity25 Bags
Recall NumberD-587-2013
Product DescriptionProplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/23/13, 04/24/13, 04/29/13, 05/01/13 Discard after: 05/20/13, 05/22/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity59 Bags
Recall NumberD-588-2013
Product DescriptionProplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/24/13 Discard after: 05/15/13
ClassificationClass II
Reason for RecallSterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity38 Bags
Recall NumberD-589-2013
Product DescriptionProplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/24/13 Discard after: 5/15/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity1 Bag
Recall NumberD-590-2013
Product DescriptionProplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/23/13 Discard after: 5/15/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity1 Bag
Recall NumberD-591-2013
Product DescriptionProplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/24/13 Discard after: 5/15/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity4 Bags
Recall NumberD-592-2013
Product DescriptionBaxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/29/13 Discard after: 5/21/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity1 Bag
Recall NumberD-593-2013
Product DescriptionBaxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Code InfoCompounding Date: 04/24/13, 04/29/13 Discard after: 5/21/13, 05/22/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity8 Bags
Recall NumberD-594-2013
Product DescriptionBaxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Code InfoCompounding Date: a) 04/26/13, b) 04/30/13 Discard after: a) and b) 5/21/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product Quantity3 Bags
Recall NumberD-595-2013

Class II Devices Event

Event ID65182
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCordis Corporation
CityMiami Lakes
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
 

Associated Products

Product DescriptionFLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Code Info27 Catalog Numbers FLX-50030-B1, FLX-60030-B1, FLX-70030-B1, FLX-80030-B1, FLX-50040-B1, FLX-60040-B1, FLX-70040-B1, FLX-80040-B1, FLX-50060-B1, FLX-60060-B1, FLX-70060-B1, FLX-80060-B1, FLX-50080-B1, FLX-60080-B1, FLX-70080-B1, FLX-80080-B1, FLX-50100-B1, FLX-60100-B1, FLX-70100-B1, FLX-80100-B1, FLX-50120-B1, FLX-60120-B1, FLX-70120-B1, FLX-80120-B1, FLX-60150-B1, FLX-70150-B1, FLX-80150-B1
ClassificationClass II
Reason for RecallHoles and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Product Quantity23 units
Recall NumberZ-1507-2013
Product DescriptionFLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT® Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Code Info28 Catalog Numbers CAC-50030-V2, CAC-60030-V2, CAC-70030-V2, CAC-80030-V2, CAC-50040-V2, CAC-60040-V2, CAC-70040-V2, CAC-80040-V2, CAC-50060-V2, CAC-60060-V2, CAC-70060-V2, CAC-80060-V2, CAC-50080-V2, CAC-60080-V2, CAC-70080-V2, CAC-80080-V2, CAC-50100-V2, CAC-60100-V2, CAC-70100-V2, CAC-80100-V2, CAC-50120-V2, CAC-60120-V2, CAC-70120-V2, CAC-80120-V2, CAC-50150-V2, CAC-60150-V2, CAC-70150-V2, CAC-80150-V2
ClassificationClass II
Reason for RecallHoles and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Product Quantity784
Recall NumberZ-1508-2013
Product DescriptionFLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Code Info27 Catalog Numbers FLX-50030-B2, FLX-60030-B2, FLX-70030-B2, FLX-80030-B2, FLX-50040-B2, FLX-60040-B2, FLX-70040-B2, FLX-80040-B2, FLX-50060-B2, FLX-60060-B2, FLX-70060-B2, FLX-80060-B2, FLX-50080-B2, FLX-60080-B2, FLX-70080-B2, FLX-80080-B2, FLX-50100-B2, FLX-60100-B2, FLX-70100-B2, FLX-80100-B2, FLX-50120-B2, FLX-60120-B2, FLX-70120-B2, FLX-80120-B2, FLX-60150-B2, FLX-70150-B2, FLX-80150-B2
ClassificationClass II
Reason for RecallHoles and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Product Quantity1357
Recall NumberZ-1509-2013
Product DescriptionFLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT® Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Code Info32 Catalog Numbers FLX-50030-V1, FLX-60030-V1, FLX-70030-V1, FLX-80030-V1, FLX-50040-V1, FLX-60040-V1, FLX-70040-V1, FLX-80040-V1, FLX-50060-V1, FLX-60060-V1, FLX-70060-V1, FLX-80060-V1, FLX-50080-V1, FLX-60080-V1, FLX-70080-V1, FLX-80080-V1, FLX-50100-V1, FLX-60100-V1, FLX-70100-V1, FLX-80100-V1, FLX-50120-V1, FLX-60120-V1, FLX-70120-V1, FLX-80120-V1, FLX-50150-V1, FLX-60150-V1, FLX-70150-V1, FLX-80150-V1, FLX-50200-V1, FLX-60200-V1, FLX-70200-V1, FLX-80200-V1
ClassificationClass II
Reason for RecallHoles and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Product Quantity250
Recall NumberZ-1510-2013
Product DescriptionFLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT® Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Code Info32 Catalog Numbers FLX-50030-V2, FLX-60030-V2, FLX-70030-V2, FLX-80030-V2, FLX-50040-V2, FLX-60040-V2, FLX-70040-V2, FLX-80040-V2, FLX-50060-V2, FLX-60060-V2, FLX-70060-V2, FLX-80060-V2, FLX-50080-V2, FLX-60080-V2, FLX-70080-V2, FLX-80080-V2, FLX-50100-V2, FLX-60100-V2, FLX-70100-V2, FLX-80100-V2, FLX-50120-V2, FLX-60120-V2, FLX-70120-V2, FLX-80120-V2, FLX-50150-V2, FLX-60150-V2, FLX-70150-V2, FLX-80150-V2, FLX-50200-V2, FLX-60200-V2, FLX-70200-V2, FLX-80200-V2
ClassificationClass II
Reason for RecallHoles and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Product Quantity310
Recall NumberZ-1511-2013

Class II Devices Event

Event ID65209
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternDistributed in New York.
 

Associated Products

Product DescriptionActive Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Code InfoPart numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.
ClassificationClass II
Reason for RecallBiomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.
Product Quantity8 units
Recall NumberZ-1465-2013

Class II Devices Event

Event ID65216
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.
 

Associated Products

Product Description8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
Code InfoModel Numbers 420179-09 and -10 and 400179-09 and -10.
ClassificationClass II
Reason for RecallIntuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.
Product Quantity~132,441 instruments
Recall NumberZ-1442-2013

Class II Devices Event

Event ID65223
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling Firm AGFA Corp.
CityGreenville
StateSC
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada
 

Associated Products

Product DescriptionAGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
Code InfoMaterial numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U
ClassificationClass II
Reason for RecallCustomers could potentially experience intermittent, unintended and illogical movement when using the product.
Product Quantity104
Recall NumberZ-1487-2013

Class II Devices Event

Event ID65224
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc
CityEast Walpole
StateMA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionADVIA Centaur® iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Code InfoReagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011
ClassificationClass II
Reason for RecalliPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Product Quantity309 (100 test) kits
Recall NumberZ-1512-2013
Product DescriptionADVIA Centaur® iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Code InfoReagent Lot Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011
ClassificationClass II
Reason for RecalliPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Product Quantity3302 Kits (500 test)
Recall NumberZ-1513-2013
Product DescriptionADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Code InfoCalibrator Lot Number: C5601 and C5602 Kit Lot Number/Exp. Date: 61405A01 27 Oct 2011 66517A02 27 Oct 2011 66611A02 27 Oct 2011 71997C02 27 Oct 2011
ClassificationClass II
Reason for RecalliPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Product Quantity99 (2 pk)
Recall NumberZ-1514-2013
Product DescriptionADVIA Centaur® iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Code InfoCalibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011
ClassificationClass II
Reason for RecalliPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Product Quantity198 (6 pk)
Recall NumberZ-1515-2013

Class II Drugs Event

Event ID65225
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionDOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Code InfoLot 11-309-KL
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Product Quantity44,748 bags
Recall NumberD-502-2013

Class II Devices Event

Event ID65255
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGyrus Acmi, Incorporated
CitySouthborough
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
 

Associated Products

Product DescriptionGYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
Code InfoJC477666
ClassificationClass II
Reason for Recalllack of sterility assurance
Product Quantity100 boxes of 6 units
Recall NumberZ-1439-2013

Class II Food Event

Event ID65256
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHP Hood LLC
CityVernon
StateNY
CountryUS
Distribution PatternNY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ, IL, FL, WI, AL, ME, OH, NE, NV, IN, and CA
 

Associated Products

Product DescriptionCottage Cheese with Chive distributed under the following labels and sizes: (a) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 16 OZ. (453g), UPC 044100102264, HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 24 OZ (680 g), UPC 044100104916, HP HOOD LLC, LYNNFIELD, MA 01940; (c) Big Y brand Small Curd Cottage Cheese With Chives, 4% MILKFAT, NET WT 16 OZ (1 LB) 453g, UPC 018894300960, DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, MA 01104.
Code InfoDate Code JUN 14 13
ClassificationClass II
Reason for RecallPossible presence of metal fragments.
Product Quantity
Recall NumberF-1471-2013
Product Description4% Cottage Cheese distributed under the following labels and sizes: (a) Hannaford brand Cottage Cheese, 4% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268114504, DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (b) Weis brand SMALL CURD original cottage cheese, 4% MILKFAT MIN., NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041497096855, PACKED FOR WEIS MARKETS, INC., SUNBURY, PA 17801; (c) Big Y brand Small Curd Cottage Cheese, 4% MILK FAT MIN, NET WT 24 OZ (680g), UPC 018894300984, DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, MA 01104; (d) Shurfine brand SMALL CURD Cottage Cheese, 4% MILKFAT, NET WT 24 OZ (1LB 8 OZ) 680g, UPC 015400832984, Distributed By: Western Family Foods, Inc. Portland, OR 97208; (e) Friendly Farms brand Small Curd Cottage Cheese, 4% MILKFAT MINIMUM, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041498192174, Distributed by ALDI, Inc., Batavia, IL 60510.
Code InfoDate Code JUN 14 13
ClassificationClass II
Reason for RecallPossible presence of metal fragments.
Product Quantity
Recall NumberF-1472-2013
Product Description1% Low Fat Cottage Cheese distributed under the following labels and sizes: (a) Fiber One brand Lowfat Cottage Cheese, 1% Milkfat Minimum, NET WT, 16 OZ (453g), UPC 041483035585, DISTRIBUTED BY HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Low Fat Cottage Cheese, SMALL CURD, 1% MILKFAT, NET WT 24 OZ (680g), UPC 044100106330; HP HOOD LLC, LYNNFIELD, MA 01940; (c) Hannaford brand Lowfat Cottage Cheese, 1% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268148615, DISTRIBUTED BY; HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (d) Weis brand lowfat cottage cheese, SMALL CURD, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041497096886, PACKED FOR WEIS MARKETS, INC., SUNBURY, PA 17801; (e) Big Y brand Small Curd Low Fat Cottage Cheese, 1% MILKFAT, NET WT 24 OZ (1 LB 8Z) 680g, UPC 018894300977, DISTRIBUTED BY: BIG Y FOODS, INC., SPRINGFIELD, MA 01104; (f) Market Basket brand Lowfat Cottage Cheese, Small Curd, 1% Milkfat, NET Wt. 24 OZ. (680g), UPC 049705682968, PACKED EXCLUSIVELY FOR DEMOULAS SUPERMARKETS INC., TEWKSBURY, MA 01876; (g) Shurfine brand LOWFAT Cottage Cheese, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 015400834605, Proudly Distributed By: Western Family Foods, Inc., Portland, OR 97208; (h) Friendly Farms brand Small Curd Cottage Cheese, Low Fat, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680 g, UPC 041498154905.
Code InfoDate Code JUN 14 13
ClassificationClass II
Reason for RecallPossible presence of metal fragments.
Product Quantity
Recall NumberF-1473-2013

Class II Devices Event

Event ID65257
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHill-Rom, Inc.
CityBatesville
StateIN
CountryUS
Distribution PatternWorldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam.
 

Associated Products

Product DescriptionHill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.
Code InfoProduct number (P1160) with Serial Numbers J143AP0937 thru O080AP5661.
ClassificationClass II
Reason for RecallComplaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.
Product Quantity8,737 devices
Recall NumberZ-1466-2013

Class II Devices Event

Event ID65258
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmZimmer Surgical Inc
CityDover
StateOH
CountryUS
Distribution PatternWorldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.
 

Associated Products

Product DescriptionThe Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Code InfoSerial Number 100211, 100338, 100515, 100560, 100647, 100755, 101104, 101345, 101562, 101769, 101890, 101983, 102560, 103407, 103509, 103816, 104529, 104863, 105049, 105072, 105604, 106394, 106474, 106624, 107861, 108103, 108203, 108210, 108339, 108911, 109445, 109543, 110034, 110837, 111046, 111047, 111048, 111049, 111050, 111051, 111052, 111053, 111054, 111055, 111056, 111057, 111058, 111059, 111060, 111061, 111062, 111063, 111064, 111065, 111066, 111067, 111068, 111069, 111071, 111072, 111073, 111074, 111075, 111076, 111079, 111081, 111083, 111084, 111085, 111086, 111087, 111089, 111090, 111091, 111092, 111096, 111100, 111101, 111102, 111104, 111105, 111116, 111121, 111122
ClassificationClass II
Reason for RecallThis removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
Product Quantity84 units
Recall NumberZ-1483-2013
Product DescriptionZimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Code InfoSerial Number 500191 , 500192,500193, 500194,500196,500197,500198,500199, 500200, 500201,500202,500203, 500204, 500205,500206, 500207,500208,500209,500210, 500211,500212, 500213,500215,500216,500217, 500219,500220, 500221,500222, 500223, 500224, 500225,500226,500227,500228,500229,500230, 500231,500232, 500233,500234,500235,500236, 500237, 500238,500239,500240,500241 , 500242, 500243,500244,500245,500246,500247,500248,500249, 500250, 500251,500252,500253,500254, 500255,500256,500257,500258,500259, 500260,500261,500262,500263,500264, 500265,500266,500267,500268,500269, 500270,500291, 500292,500293,500295,500296,500297,500298, 500299,500300,500301 , 500302,500303, 500304, 500306, 500307,500308,500309,500310, 500331 , 500332, 500334, 500335, 500336, 500337, 500338, 500339, 500340, 500341,500342, 500343, 500344, 500345, 500346, 500347, 500348,500349, 500350, 500351 , 500352, 500353, 500354,500355, 500357, 500358, 500359, 500368, 500369,500370,500371
ClassificationClass II
Reason for RecallThis removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
Product Quantity126 units
Recall NumberZ-1484-2013
Product DescriptionZimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.
Code InfoSerial Number 500311, 500312, 500317, 500320, 500321, 500322, 500323, 500324, 500325, 500326, 500327, 500328, 500329
ClassificationClass II
Reason for RecallThis removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
Product Quantity13 units
Recall NumberZ-1485-2013

Class II Drugs Event

Event ID65269
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Apr-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPhysicians Total Care, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMetronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.
Code InfoEntry Format for Lots is: PTC Lot #; Exp Date; Distributor Bulk Lot #.PTC Lot #614S; Exp 05/31/2013; Teva Lot #14108110A. PTC Lot #6HFC; Exp 06/30/2013; Teva Lot #14127710A. PTC Lot #615S; Exp 08/31/2013; Teva Lot #14180910A. PTC Lot #4614; Exp 04/30/2011; Barr Lot #306670. PTC Lot #46TQ; Exp 04/30/2011; Barr Lot #306670. PTC Lot #48GN; Exp 05/31/2011; Barr Lot #307039. PTC Lot #4A36; Exp 05/31/2011; Barr Lot #307127. PTC Lot#4AA9; Exp 05/31/2011; Barr Lot #307127. PTC Lot #4ASM; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4AWE; Exp 05/31/2011; Barr Lot# 307128. PTC Lot #4AWG; Exp 05/31/2011; Barr Lot#307128. PTC Lot#4AZR; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4B72; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4C50; Exp 06/30/2011; Barr Lot #307360. PTC Lot# 4BOZ; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4BPO; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4E2R; Exp 07/31/2011; Barr Lot #307901. PTC Lot #4D68; Exp 08/31/2011; Barr Lot #307953. PTC Lot #4ETP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Y; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Z; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4FCP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GCM; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GY4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HR8; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HZ4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4IE9; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4J14; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JBR; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JN3; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JQ0; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KFL; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KT7; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4L2L; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4LWK; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MAL; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MEY; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MX9; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBB; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBZ; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4O56; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4ORJ; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4PEJ; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4PL1; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4QQF; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4R6O; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4RSK; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4S1U; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4SFI; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4SRT; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4TB2; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4U8D; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4V2G; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4VJG; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4X6N; Exp 12/31/2011; Barr Lot #311069. PTC Lot #4Y9Q; Exp 12/31/2011; Barr Lot #311069. PTC Lot #4XVB; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4XZH; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4Y9P; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5031; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5172; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5698; Exp 12/31/2011; Barr Lot #311074. PTC Lot #56NJ; Exp 12/31/2011; Barr Lot #311074. PTC Lot #56NL; Exp 12/31/2011; Barr Lot #311074. PTC Lot #58XM; Exp 12/31/2011; Barr Lot #311074. PTC Lot #59D2; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4WEJ; Exp 01/31/2012; Barr Lot #311075. PTC Lot #527Z; Exp 12/31/2011; Barr Lot #311145. PTC Lot #52FT; Exp 12/31/2011; Barr Lot #311145. PTC Lot #5328; Exp 12/31/2011; Barr Lot #311145. PTC Lot #53CU; Exp 12/31/2011; Barr Lot #311145. PTC Lot #54AE; Exp 12/31/2011; Barr Lot #311145. PTC Lot #557T; Exp 12/31/2011; Barr Lot #311145. PTC Lot #55QA; Exp 02/28/2012; Barr Lot #311365. PTC Lot #563R; Exp 02/28/2012; Barr Lot #311365. PTC Lot #57WL; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5ASQ; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5BTD; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5BZ9; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5CCB; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5CO2; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5DXG; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5F86; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5KE5; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5KJS; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5KSX; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5DIO; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5DUW; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5H9T; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5HZ3; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5I1B; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5IJ2; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5J2T; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5LPO; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5ME4; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5MNG; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5N7Q; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5OC6; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5PRW; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5QOH; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5QOI; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5RGR; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5RGT; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5OLD; Exp 01/31/2013; Barr Lot #315019. PTC Lot #5TWL; Exp 01/31/2013; Barr Lot #315021. PTC Lot #5SXH; Exp 12/31/2012; Barr Lot #315023. PTC Lot #5T2J; Exp 12/31/2012; Barr Lot #315023. PTC Lot #5TWK; Exp 01/31/2013; Barr Lot #315181. PTC Lot #5U96; Exp 01/31/2013; Barr Lot #315181. PTC Lot #5VDI; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5VNI; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5W14; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5W9R; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5WNV; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOC; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOD; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOE; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5UHJ; Exp 02/28/2013; Barr Lot #315679. PTC Lot #5UUI; Exp 02/28/2013; Barr Lot #315679. PTC Lot #5ZKM; Exp 02/28/2013; Barr Lot #315836. PTC Lot #5ZKN; Exp 02/28/2013; Barr Lot #315836. PTC Lot #60CN; Exp 02/28/2013; Barr Lot #315836. PTC Lot #68C8; Exp 02/28/2013; Barr Lot #316205. PTC Lot #68U6; Exp 02/28/2013; Barr Lot #316205. PTC Lot #68UH; Exp 02/28/2013; Barr Lot #316205. PTC Lot #69QO; Exp 02/28/2013; Barr Lot #316205. PTC Lot #60NB; Exp 11/30/2012; Barr Lot #316241. PTC Lot #60UT; Exp 11/30/2012; Barr Lot #316241. PTC Lot #60UU; Exp 11/30/2012; Barr Lot #316241. PTC Lot #615Y; Exp 11/30/2012; Barr Lot #316241. PTC Lot #6168; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61KO; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61KP; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61RM; Exp 11/30/2012; Barr Lot #316241. PTC Lot #62CO; Exp 03/31/2013; Barr Lot #316298. PTC Lot #63CZ; Exp 03/31/2013; Barr Lot #316298. PTC Lot #63M7; Exp 03/31/2013; Barr Lot #316298. PTC Lot #64AW; Exp 03/31/2013; Barr Lot #316298. PTC Lot #64VH; Exp 03/31/2013; Barr Lot #316450. PTC Lot #6513; Exp 03/31/2013; Barr Lot #316450. PTC Lot #62HE; Exp 03/31/2013; Barr Lot #316622. PTC Lot #66KC; Exp 03/31/2013; Barr Lot #316626. PTC Lot #66KD; Exp 03/31/2013; Barr Lot #316626. PTC Lot #66MC; Exp 03/31/2013; Barr Lot #316626. PTC Lot #683O; Exp 03/31/2013; Barr Lot #316772. PTC Lot #6G1B; Exp 04/30/2013; Barr Lot #317017. PTC Lot #6G1C; Exp 04/30/2013; Barr Lot #317017. PTC Lot #69GY; Exp 03/31/2013; Barr Lot #317018. PTC Lot #69GZ; Exp 03/31/2013; Barr Lot #317018. PTC Lot #69H0; Exp 03/31/2013; Barr Lot #317018. PTC Lot #6G2G; Exp 05/31/2013; Barr Lot #317477. PTC Lot #6GOH; Exp 05/31/2013; Barr Lot #317479. PTC Lot # 494L; Exp 04/30/2011; Barr Lot #701252. PTC Lot #49K7; Exp 04/30/2011; Barr Lot #701252.
ClassificationClass II
Reason for RecallFailed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Product Quantity25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles
Recall NumberD-547-2013

Class II Devices Event

Event ID65314
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmColoplast Manufacturing US, LLC
CityMinneapolis
StateMN
CountryUS
Distribution PatternUS Distribution to: KY, MI, OH, PR, TX, and VA.
 

Associated Products

Product DescriptionDigitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
Code InfoLots 3390331, 3390339, 3390490.
ClassificationClass II
Reason for RecallColoplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.
Product Quantity772 units
Recall NumberZ-1486-2013

Class II Drugs Event

Event ID65315
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionDiazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Code Info17-099-EV Exp 05/14
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product Quantity95,700 vials
Recall NumberD-501-2013

Class II Devices Event

Event ID65321
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmStryker Instruments Div. of Stryker Corporation
CityPortage
StateMI
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product DescriptionStryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1006134, 1101020, 1106424
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity2,980 units (298 boxes)
Recall NumberZ-1489-2013
Product DescriptionStryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1005105, 1010244, 1101004, 1104289, 1107568, 1005119, 1010261, 1101030, 1104324, 1108625, 1006129, 1011276, 1101047, 1105390, 1108672, 1006140, 1011296, 1102073, 1105355, 1109730, 1007151, 1012314, 1102127, 1106431, 1109782, 1007163, 1012337, 1102131, 1106467, 1109858, 1009213, 1012346, 1104253, 1107515.
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity48,040 units, ( 4804 boxes)
Recall NumberZ-1490-2013
Product DescriptionStryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1007157, 1103202
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity1,980 units (198 boxes)
Recall NumberZ-1491-2013
Product DescriptionStryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1005111, 1011282,1107491, 1107492
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity3,000 units (300 boxes)
Recall NumberZ-1492-2013
Product DescriptionStryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1006134, 1012304, 1104308, 1007152, 1101020, 1105365, 1007170, 1102080, 1106421, 1008188, 1102147, 1106469, 1009205, 1103193, 1108628, 1010229, 1103198, 1108697, 1010253, 1102149, 1109789, 1011277, 1104248
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity34,640 units (3,464 boxes)
Recall NumberZ-1493-2013
Product DescriptionStryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1005105, 1009214, 1104308, 1006130, 1010260, 1104312, 1007152, 1012346, 1105378, 1007163, 1012303, 1106460, 1007164, 1101062, 1107542, 1008189, 1101063, 1108660, 1008188, 1102149, 1109760, 1009213, and 1103219.
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity21,660 units (2166 boxes)
Recall NumberZ-1494-2013
Product DescriptionStryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1006129, 1103201, 1009197, 1105391, 1009198, 1107548, 1012302, 1109788, and 1102127
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity7960 units (796 boxes)
Recall NumberZ-1495-2013
Product DescriptionStryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1005097, 1009205, 1011294, 1102105, 1104268, 1106463, 1108633, 1109857, 1005098, 1009219, 1012313, 1102109, 1104305, 1106465, 1108648, 1109812, 1005104, 1008192, 1011281, 1102119, 1104307, 1106470, 1108654, 1109860, 1005105, 1009213, 1012325, 1102123, 1104308, 1107493, 1108659, 1109817, 1005110, 1009197, 1012327, 1102141, 1104320, 1107488, 1108666, 1005111, 1009204, 1012335, 1102147, 1104327, 1107497, 1108667, 1005118, 1010227, 1012345, 1102150, 1105370, 1106474, 1108671, 1006123, 1010234, 1101014, 1103170, 1105342, 1107511, 1108675, 1007155, 1010235, 1012344, 1103171, 1105356, 1107512, 1108701, 1006127, 1010251, 1101003, 1103223, 1105110, 1107516, 1108704, 1006133, 1010258, 1101017, 1103189, 1105379, 1107537, 1109778, 1006140, 1010243, 1101002, 1103194, 1105390, 1107546, 1107520, 1008181, 1012314, 1101029, 1103184, 1105401, 1107595, 1108710, 1007163, 1010259, 1101046, 1103227, 1106418, 1107604, 1108713, 1007145, 1010252, 1101053, 1104280, 1106432, 1107561, 1109740, 1007156, 1011266, 1102073, 1104248, 1106453, 1108624, 1109750, 1007169, 1011267, 1102092, 1104259, 1106444, 1107599, 1109729, 1007151, 1011275, 1101055, 1104264, 1106451, 1107567, 1109735, 1008176, 1011280, 1102085, 1104290, 1106437, 1107578, 1109755, 1008178, 1011295, 1102099, 1104278, 1106455, 1107570, 1109781, 1008188, 1011276, 1102080, 1104283, 1106460, 1108619, and 1109809.
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity334,520 units (33,452 boxes)
Recall NumberZ-1496-2013
Product DescriptionStryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1007145, 1101004, 1107487
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity3000 units (300 boxes)
Recall NumberZ-1497-2013
Product DescriptionStryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1005098, 1010228, 1012337, 1105367
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity3,980 units ( 398 boxes)
Recall NumberZ-1498-2013
Product DescriptionStryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 11097861006141, 1012303, 1102110, 1104324, and 1108664.
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity25,770 units (2,577 boxes)
Recall NumberZ-1499-2013
Product DescriptionStryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1006141, 1012303, 1102110, 1104324, and 1108664
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity5,000 units ( 500 boxes)
Recall NumberZ-1500-2013
Product DescriptionStryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1105390, 1107543
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity9,930 units (993 boxes)
Recall NumberZ-1501-2013
Product DescriptionStryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1005097, 1008188, 1011281, 1103194, 1106465, 1107519, 1005105, 1008192, 1011296, 1103201, 1107501, 1109763, 1005111, 1009198, 1012303, 1103223, 1107550, 1109777, 1005118, 1009213, 1012314, 1104282, 1107560, 1109822, 1006129, 1009219, 1012325, 1104290, 1107605, 1109850, 1008181, 1009220, 1012335, 1104320, 1107606, 1006135, 1010228, 1012344, 1104312, 1108618, 1007145, 1010236, 1101003, 1105346, 1108663, 1007151, 1010235, 1101030, 1105355, 1108677, 1007156, 1010243, 1101055, 1105378, 1108709, 1007163, 1010252, 1102109, 1106411, 1108714, 1007169, 1010260, 1102123, 1105405, 1109728, 1008183, 1011276, 1102141, 1106430, and 1104275.
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity88,040 units (8,804 boxes)
Recall NumberZ-1502-2013
Product DescriptionStryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1010236, 1108682
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity2,000 units ( 200 boxes)
Recall NumberZ-1503-2013
Product DescriptionStryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Info1006124, 1007164, 1010236, 1011296, 1103168, 1105341, and 1108634.
ClassificationClass II
Reason for RecallBased on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Product Quantity6,990 units ( 699 boxes)
Recall NumberZ-1504-2013

Class III Biologics Event

Event ID50723
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Dec-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW037908102316
ClassificationClass III
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 Unit
Recall NumberB-1265-13

Class III Devices Event

Event ID64164
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jan-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBion Enterprises Ltd
CityDes Plaines
StateIL
CountryUS
Distribution PatternWorldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)
 

Associated Products

Product DescriptionPlastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
Code InfoProduct Code: CCG-9912; Lot: CCG-0280
ClassificationClass III
Reason for RecallAffected products have a labeled expiration date of one year too long.
Product Quantity207 units
Recall NumberZ-1477-2013
Product DescriptionPlastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
Code InfoProduct Code: CCM-9914; Lot: CCM-0281
ClassificationClass III
Reason for RecallAffected products have a labeled expiration date of one year too long.
Product Quantity201 units
Recall NumberZ-1478-2013
Product DescriptionPlastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
Code InfoProduct Code: CCG-9972; Lot: CCG-0281
ClassificationClass III
Reason for RecallAffected products have a labeled expiration date of one year too long.
Product Quantity504 units
Recall NumberZ-1479-2013

Class III Drugs Event

Event ID64372
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNovartis Consumer Health
CityLincoln
StateNE
CountryUS
Distribution PatternNationwide and Puerto Rico, and Panama. Military distribution made.
 

Associated Products

Product DescriptionNovartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.
Code Info(12 gm) Lot numbers and Exp dates: 10109586 30-Apr-2013, 10116816 31 May 2013, 10117695 31-Jul-2013, 10120283 31-Aug-2013, 10104980 28-Feb-2013, 10108711 31-Mar-2013, 10111313 30-Apr-2013, 10111509 30-Apr-2013, 10115506 30-Jun-2013, 10117696 30-Jun-2013, 10120763 31-Aug-2013, 10122695 30-Sep-2013, 10104983 28-Feb-2013, 10108714 31-Mar-2013, 10119643 31-Jul-2013 (30 gm) Lot numbers and Exp dates: 10104979 28-Feb-2013 10108712 31-Mar-2013 10109588 30-Apr-2013 10111507 30-Apr-2013 10115133 31-May-2013 10115619 30-Jun-2013 10117694 31-Aug-2013 10120762 30-Sep-2013 10109981 31-Mar-2013 10111316 31-Mar-2013 10114223 31-May-2013 10117697 30-Jun-2013 10104982 28-Feb-2013 10108355 31-Mar-2013, 10112072 30-Apr-2013, 10112073 30-Apr-2013 10113501 31-May-2013, 10122772 31-Aug-2013
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Product Quantity818,064 (12-gm) tubes and 836,376 (30-gm) tubes
Recall NumberD-573-2013
Product DescriptionTarget Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN.
Code InfoLot numbers and exp dates: 10108716 31-Mar-2013, 10111510 30-Apr-2013, 10113801 31-May-2013, 10113839 30-Apr-2013, 10115616 31-Aug-2013
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
Product Quantity99,660 tubes
Recall NumberD-574-2013
Product DescriptionNovartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428.
Code InfoLot number and exp date: 10104145 30-Apr-2013. (Vertical package) and Lot number and exp date: 10109587 30-Apr-2013, 10111508 31-May-2013; 10119095 31-Jul-2013 and 10119096 30-Sep-2013 (Horizontal package).
ClassificationClass III
Reason for RecallThe products have illegible lot and/or expiration dates on the product container.
Product Quantity219,600 tubes
Recall NumberD-575-2013
Product DescriptionLamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43
Code InfoLot #: 10109590, 10111050, Exp 2/28/13.
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Product Quantity41,400 Boxes
Recall NumberD-576-2013
Product DescriptionVoltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.
Code InfoLot #'s and Expiration dates: a) 20 gm tubes: 10116298 05/31/14 10116299 05/31/14 10116300 05/31/14 10117402 07/31/14 10117403 07/31/14 10117404 08/31/14 10117405 08/31/14 10117406 08/31/14 10117407 10/31/14 10117408 10/31/14 b) 100 gm tubes: 10119436 10119436 10119437 10119437 10119438 10119438 10119439 10119439 10119440 10119440 10119441 10119441 10119442 10119442 10119443 10119443 10119444 10119444 10119445 10119445 10119446 10119446 100 gm/3 pack: 10085217 2/28/2013 10085218 2/28/2013 10085219 2/28/2013 10085220 2/28/2013 10085221 2/28/2013 10085222 2/28/2013 10085223 2/28/2013 10085224 2/28/2013 10085225 2/28/2013 10085226 2/28/2013 10085227 2/28/2013 10085228 2/28/2013 10085229 2/28/2013 10085230 2/28/2013 10085231 2/28/2013 10085232 2/28/2013 10085233 2/28/2013 10085234 2/28/2013 10085235 2/28/2013 10085236 2/28/2013 10085238 2/28/2013 10085239 2/28/2013 10085240 2/28/2013 10085241 2/28/2013 10085242 2/28/2013 10085243 2/28/2013 10085244 2/28/2013 10085245 2/28/2013 10085246 3/31/2013 10085247 3/31/2013 10085248 3/31/2013 10085249 3/31/2013 10085260 3/31/2013 10085261 3/31/2013 10085262 3/31/2013 10085263 3/31/2013 10085264 3/31/2013 10085265 3/31/2013 10085266 3/31/2013 10085267 3/31/2013 10085268 3/31/2013 10085269 3/31/2013 10085270 3/31/2013 10085271 3/31/2013 10085272 3/31/2013 10087039 3/31/2013 10087040 3/31/2013 10087041 3/31/2013 10087042 3/31/2013 10087043 3/31/2013 10087052 3/31/2013 10087053 3/31/2013 10087054 3/31/2013 10087055 3/31/2013 10087063 3/31/2013 10087064 3/31/2013 10087065 3/31/2013 10088276 4/30/2013 10088277 4/30/2013 10088278 4/30/2013 10088279 4/30/2013 10088280 4/30/2013 10088281 4/30/2013 10088282 4/30/2013 10088289 4/30/2013 10088290 4/30/2013 10088291 4/30/2013 10088292 4/30/2013 10088293 4/30/2013 10088294 4/30/2013 10088295 4/30/2013 10088296 4/30/2013 10088297 4/30/2013 10088298 4/30/2013 10088299 4/30/2013 10088300 4/30/2013 10088301 4/30/2013 10088302 4/30/2013 10088303 4/30/2013 10088304 4/30/2013 10088305 4/30/2013 10088306 4/30/2013 10088307 4/30/2013 10088308 4/30/2013 10088309 4/30/2013 10088310 4/30/2013 10088311 4/30/2013 10088312 4/30/2013 10088313 4/30/2013 10088314 4/30/2013 10088315 4/30/2013 10088897 5/31/2013 10088898 5/31/2013 10088899 5/31/2013 10088900 5/31/2013 10088901 5/31/2013 10088902 5/31/2013 10088903 5/31/2013 10088904 5/31/2013 10088905 5/31/2013 10088906 5/31/2013 10088907 5/31/2013 10088908 5/31/2013 10088909 5/31/2013 10088910 5/31/2013 10088911 6/30/2013 10088921 7/31/2013 10088922 7/31/2013 10088923 7/31/2013 10088924 7/31/2013 10088925 7/31/2013 10088926 7/31/2013 10088927 7/31/2013 10088928 7/31/2013 10088929 7/31/2013 10088930 7/31/2013 10088931 7/31/2013 10090306 4/30/2013 10090307 4/30/2013 10090308 4/30/2013 10092277 7/31/2013 10092278 7/31/2013 10092279 7/31/2013 10092280 7/31/2013 10092281 7/31/2013 10092282 7/31/2013 10092283 7/31/2013 10092284 8/31/2013 10092285 8/31/2013 10092288 8/31/2013 10092289 8/31/2013 10092290 8/31/2013 10092291 8/31/2013 10092292 8/31/2013 10092293 8/31/2013 10092294 8/31/2013 10094387 8/31/2013 10094388 8/31/2013 10094389 8/31/2013 10094390 8/31/2013 10094394 9/30/2013 10094395 9/30/2013 10094396 9/30/2013 10094397 9/30/2013 10094398 9/30/2013 10097030 9/30/2013 10097031 9/30/2013 10097032 9/30/2013 10097033 9/30/2013 10097035 10/31/2013 10097036 10/31/2013 10098681 10/31/2013 10098692 10/31/2013 10098693 10/31/2013 10098694 10/31/2013 10098695 10/31/2013 10098697 10/31/2013 10098698 10/31/2013 10098699 10/31/2013 10098700 10/31/2013 10098701 10/31/2013 10098702 10/31/2013 10098703 10/31/2013 10098704 10/31/2013 10098708 11/30/2013 10098709 11/30/2013 10100515 11/30/2013 10100516 11/30/2013 10100517 11/30/2013 10100524 12/31/2013 10100525 12/31/2013 10100526 12/31/2013 10100527 12/31/2013 10100528 12/31/2013 10102312 12/31/2013 10102313 12/31/2013 10102314 12/31/2013 10102315 12/31/2013 10102316 12/31/2013 10102317 12/31/2013 10102318 12/31/2013 10102319 1/31/2014 10102320 1/31/2014 10102321 1/31/2014 10102322 1/31/2014 10102323 1/31/2014 10102324 1/31/2014 10102325 1/31/2014 10102326 1/31/2014 10102328 1/31/2014 10102329 1/31/2014 10102330 1/31/2014 10102331 1/31/2014 10102332 1/31/2014 10102337 1/31/2014 10102338 1/31/2014 10104246 2/28/2014 10104247 2/28/2014 10104248 2/28/2014 10104249 2/28/2014 10104250 2/28/2014 10104251 2/28/2014 10104252 2/28/2014 10104257 2/28/2014 10104258 2/28/2014 10104259 2/28/2014 10104260 2/28/2014 10104261 2/28/2014 10104262 2/28/2014 10107735 2/28/2014 10107736 3/31/2014 10107737 3/31/2014 10107738 3/31/2014 10107739 3/31/2014 10107740 3/31/2014 10107741 3/31/2014 10107749 3/31/2014 10107750 3/31/2014 10107751 3/31/2014 10107752 3/31/2014 10107753 3/31/2014 10107754 3/31/2014 10110430 4/30/2014 10110431 4/30/2014 10110432 4/30/2014 10110433 4/30/2014 10110434 4/30/2014 10110435 4/30/2014 10110436 4/30/2014 10110437 4/30/2014 10110438 4/30/2014 10110439 4/30/2014 10110440 4/30/2014 10110441 4/30/2014 10110442 4/30/2014 10110443 4/30/2014 10110444 4/30/2014 10111080 4/30/2014 10111081 4/30/2014 10111082 5/31/2014 10111083 5/31/2014 10113475 5/31/2014 10113476 5/31/2014 10113477 5/31/2014 10113478 5/31/2014 10113479 5/31/2014 10113480 5/31/2014 10113481 5/31/2014 10113482 5/31/2014 10113483 5/31/2014 10113484 5/31/2014 10113485 6/30/2014 10113486 6/30/2014 10113487 6/30/2014 10113488 6/30/2014 10113489 6/30/2014 10113490 6/30/2014 10115859 6/30/2014 10115860 6/30/2014 10115861 6/30/2014 10115862 6/30/2014 10115863 6/30/2014 10115864 6/30/2014 10115865 6/30/2014 10115866 6/30/2014 10115867 6/30/2014 10115868 6/30/2014 10115869 6/30/2014 10115870 6/30/2014 10115871 7/31/2014 10115872 7/31/2014 10115873 7/31/2014 10115876 7/31/2014 10115877 7/31/2014 10115878 7/31/2014 10117411 7/31/2014 10117413 7/31/2014 10117414 7/31/2014 10117416 7/31/2014 10117417 7/31/2014 10119416 9/30/2014 10119417 9/30/2014 10119418 9/30/2014 10119419 9/30/2014 10119420 9/30/2014 10119429 9/30/2014 10119430 9/30/2014 10119431 9/30/2014 10119432 9/30/2014 10119433 10/31/2014 10119434 10/31/2014 10120546 8/31/2014 10120547 8/31/2014 10120548 8/31/2014 10120549 8/31/2014 10120550 8/31/2014 10120551 8/31/2014 10120552 8/31/2014 10120553 8/31/2014 10120554 8/31/2014 10120555 9/30/2014 10120556 9/30/2014 10120557 9/30/2014 10120558 9/30/2014 100 gm/5 pack: 10085250 3/31/2013 10085251 3/31/2013 10085252 3/31/2013 10085253 3/31/2013 10085254 3/31/2013 10085255 3/31/2013 10085256 3/31/2013 10085257 3/31/2013 10085258 3/31/2013 10085259 3/31/2013 10087044 3/31/2013 10087048 3/31/2013 10087049 3/31/2013 10087050 3/31/2013 10087051 3/31/2013 10087056 3/31/2013 10087057 3/31/2013 10087058 3/31/2013 10087059 3/31/2013 10087060 3/31/2013 10087061 3/31/2013 10087062 3/31/2013 10088283 4/30/2013 10088284 4/30/2013 10088285 4/30/2013 10088286 4/30/2013 10088287 4/30/2013 10088288 4/30/2013 10088912 6/30/2013 10088913 6/30/2013 10088914 6/30/2013 10088915 6/30/2013 10088916 6/30/2013 10088917 6/30/2013 10088918 6/30/2013 10088919 6/30/2013 10088920 7/31/2013 10092286 8/31/2013 10092287 8/31/2013 10094391 8/31/2013 10094392 8/31/2013 10094393 9/30/2013 10097029 9/30/2013 10097034 9/30/2013 10098696 10/31/2013 10098705 10/31/2013 10098706 10/31/2013 10098707 11/30/2013 10100518 11/30/2013 10100519 11/30/2013 10100520 11/30/2013 10100521 11/30/2013 10100522 12/31/2013 10100523 12/31/2013 10102327 1/31/2014 10102333 1/31/2014 10102334 1/31/2014 10102335 1/31/2014 10102336 1/31/2014 10104253 2/28/2014 10104254 2/28/2014 10104255 2/28/2014 10104256 2/28/2014 10107742 3/31/2014 10107743 3/31/2014 10107744 3/31/2014 10107745 3/31/2014 10107746 3/31/2014 10107747 3/31/2014 10107748 3/31/2014 10111084 5/31/2014 10111085 5/31/2014 10111086 5/31/2014 10111087 5/31/2014 10111088 5/31/2014 10111089 5/31/2014 10111090 5/31/2014 10115874 7/31/2014 10115875 7/31/2014 10117412 7/31/2014 10117415 7/31/2014 10119409 7/31/2014 10119410 7/31/2014 10119411 7/31/2014 10119412 8/31/2014 10119413 8/31/2014 10119414 8/31/2014 10119415 8/31/2014 10119435 10/31/2014 10119436 10/31/2014
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Product Quantitya) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes
Recall NumberD-577-2013

Class III Biologics Event

Event ID64430
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Bank of Erie County
CityErie
StatePA
CountryUS
Distribution PatternPennsylvania; New York
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW045613818099; W045613818100; W045613818110;
ClassificationClass III
Reason for RecallBlood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed.
Product Quantity3
Recall NumberB-1384-13

Class III Drugs Event

Event ID64680
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionDisulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
Code InfoNDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015.
ClassificationClass III
Reason for RecallCGMP Deviation; cotton coil is missing in some packaged bottles
Product Quantity68,322 bottles
Recall NumberD-578-2013

Class III Drugs Event

Event ID64794
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLegacy Pharmaceutical Packaging LLC
CityEarth City
StateMO
CountryUS
Distribution PatternDistribution was made to IN.
 

Associated Products

Product DescriptionLorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Code InfoL-04009 Exp.11/15
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Product Quantity1,644 bottles
Recall NumberD-580-2013

Class III Biologics Event

Event ID64849
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmImmucor Inc
CityNorcross
StateGA
CountryUS
Distribution PatternNationwide; Brazil, China, Costa Rica, Germany, Hong Kong, India, Ireland, Mexico, Singapore, Taiwan
 

Associated Products

Product DescriptionCapture-P Indicator Red Cells package 1 x 11.5 mL
Code InfoLot Nos. 226192, 22613, 226194
ClassificationClass III
Reason for RecallCapture-P and Capture-P Ready Screen assays, with confirmed reduced reactivity with the weak positive control, were distributed.
Product Quantity3 units
Recall NumberB-1482-13

Class III Biologics Event

Event ID64864
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmArkansas Lions Eye Bank & Laboratory
CityLittle Rock
StateAR
CountryUS
Distribution PatternArkansas
 

Associated Products

Product DescriptionCornea
Code Info1302059; 1302060;
ClassificationClass III
Reason for RecallHuman Cornea, recovered from a donor whose donor eligibility was not determined in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed.
Product Quantity2 corneas
Recall NumberB-1495-13

Class III Biologics Event

Event ID64865
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmNorth Carolina Eye Bank, Inc. (The)
CityWinston Salem
StateNC
CountryUS
Distribution PatternEgypt
 

Associated Products

Product DescriptionCornea
Code Info06431301; 06431302
ClassificationClass III
Reason for RecallHuman Corneas, recovered using an expired Prep Kit, were distributed.
Product Quantity2 corneas
Recall NumberB-1494-13

Class III Food Event

Event ID65030
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmProsperity Resources International, Inc.
CityLinden
StateNJ
CountryUS
Distribution PatternRetail customers in New York State.
 

Associated Products

Product DescriptionGolden Flower Dried Ginger Net Wt. 6 oz (170g). Packed By: S&Y Co., LTD. No 12 Yuenjiang Road, Gaoming City Guangdong, China. Distributed by: Prosperity Resources Int'l., Inc. USA. Product of China.
Code InfoUPC 64740601186
ClassificationClass III
Reason for RecallThe Golden Flower Dried Ginger (Net Weight 6 oz. 170 gms) Product of China is in violations to the Agriculture and Markets Law.
Product Quantity50 cases (each case contains 50 individual 6 oz. plastic packages)
Recall NumberF-1504-2013

Class III Food Event

Event ID65186
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmArizona Beverages USA LLC
CityWoodbury
StateNY
CountryUS
Distribution PatternCT, PA, NY, NJ, MI, IL and WI.
 

Associated Products

Product DescriptionORIGINAL BRAND Arizona SOUTHERN STYLE UNSWEETENED Brewed Tea, Net Wt. 128 FL.OZ (1 GAL.). Product is packaged in a cardboard case, each case contains four 1 Gallon plastic containers. UPC Code: 6 1300871981 4.
Code InfoCodes: KP 072 13 {1004} CT120. Starting with the time stamp code at 10.04 am and onward
ClassificationClass III
Reason for RecallUndeclared Splenda ingredient.
Product Quantity8,989 cases (4 containers per case)
Recall NumberF-1466-2013

Class III Devices Event

Event ID65191
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOptovue, Inc.
CityFremont
StateCA
CountryUS
Distribution PatternDistributed Nationwide and in Canada.
 

Associated Products

Product DescriptionOptovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Code InfoiVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
ClassificationClass III
Reason for RecallColors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
Product Quantity~329 users
Recall NumberZ-1441-2013

Class III Drugs Event

Event ID65295
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPhysicians Total Care, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionVoltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00
Code InfoPTC Lot #; Exp Date; Distributor Novartis Lot #. PTC #651L; Exp 03/31/2013; Novartis #10085272. PTC #G8OO; Exp 04/30/2013; Novartis #10088292. PTC #67GO; Exp 04/30/2013; Novartis #10088311. PTC #67J7; Exp 04/30/2013; Novartis #10088311. PTC #68JC; Exp 05/31/2013; Novartis #10088899. PTC #68KA; Exp 05/31/2013; Novartis #10088899. PTC #6B0I; Exp 05/31/2013; Novartis #10088905. PTC #6AA4; Exp 05/31/2013; Novartis #10088907. PTC #6D9R; Exp 07/31/2013; Novartis #10088924. PTC #6DBP; Exp 07/31/2013; Novartis #10088925. PTC #6M81; Exp 07/31/2013; Novartis #10088929. PTC #6ME2; Exp 07/31/2013; Novartis #10088929. PTC #6F98; Exp 08/31/2013; Novartis #10094389. PTC #6QFU; Exp 09/30/2013; Novartis #10094396. PTC #6I2S; Exp 10/31/2013; Novartis #10098702. PTC #6KJG; Exp 12/31/2013; Novartis #10102313. PTC #6KC1; Exp 12/31/2013; Novartis #10102314. PTC #6SQ7; Exp 02/28/2014; Novartis #10104248. PTC #6Q3B; Exp 03/31/2014; Novartis #10107749. PTC #6NRO; Exp 03/31/2014; Novartis #10107750. PTC #6OVH; Exp 03/31/2014; Novartis #10107750. PTC #6QTV; Exp 04/30/2014; Novartis #10110442. PTC #6REN; Exp 04/30/2014; Novartis #10110442. PTC #6ROG; Exp 04/30/2014; Novartis #10110442. PTC #6VGM; Exp 05/31/2014; Novartis #10113476. PTC #6VOR; Exp 05/31/2014; Novartis #10113476. PTC #6VQ2; Exp 05/31/2014; Novartis #10113476. PTC #6VWW; Exp 05/31/2014; Novartis #10113476. PTC #6SQ6; Exp 05/31/2014; Novartis #10113478. PTC #6XO2; Exp 05/31/2014; Novartis #10113481. PTC #6Y4L; Exp 05/31/2014; Novartis #10113481. PTC #6YTH; Exp 05/31/2014; Novartis #10113481. PTC #6V3L; Exp 06/30/2014; Novartis #10115860. PTC #6X79; Exp 09/30/2014; Novartis #10119418. PTC #6WQ4; Exp 09/30/2014; Novartis #10120557.
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.
Product Quantity76 Tubes
Recall NumberD-596-2013

Mixed Classification Biologics Event

Event ID64379
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityShreveport
StateLA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionFresh Frozen Plasma (Apheresis)
Code InfoW036512123500; W036512123495;
ClassificationClass III
Reason for RecallBlood products, labeled with an incorrect expiration dates, were distributed.
Product Quantity2
Recall NumberB-1274-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW036512123499; W036512123500; W036512123495; W036512123497; W036512123795; W036512123796; W036512123792; W036512123792; W036512123793; W036512123793; W036512123794; W036512123499;
ClassificationClass II
Reason for RecallBlood products, labeled with an incorrect expiration dates, were distributed.
Product Quantity12
Recall NumberB-1275-13

Mixed Classification Biologics Event

Event ID64429
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland; Florida; New York
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info2935922; 2917309; 2906733;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1409-13
Product DescriptionFresh Frozen Plasma
Code Info2615454; 2536100; 1791712; 1692582; 1699599;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity5
Recall NumberB-1410-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW036810024856; W036810024856; W036808146279; W036808146279; 2084027; 2084027; 9638986;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity7
Recall NumberB-1411-13
Product DescriptionPlatelets
Code Info1791712; 9671521; 9638986;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1412-13
Product DescriptionRed Blood Cells
Code Info2615454; 2536100; 2351667; 1791712; 1692582; 1699599; 9671521; 9458747;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity8
Recall NumberB-1413-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2351667; 9671521; 9638986; 9458747;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-1414-13

Mixed Classification Biologics Event

Event ID64462
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Svs. Indiana-Ohio Region
CityFort Wayne
StateIN
CountryUS
Distribution PatternCalifornia; Indiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info038GZ69902;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1467-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info038GZ69902; 038Y79139;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1468-13

Mixed Classification Biologics Event

Event ID64474
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2625668;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1380-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2625668;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1381-13

Mixed Classification Biologics Event

Event ID64516
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood / dba CBCF
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812599383;
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1351-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036812599383;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1352-13
Product DescriptionRed Blood Cells
Code InfoW036812566971;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1353-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036812843768;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1354-13
Product DescriptionFresh Frozen Plasma
Code InfoW036812566971;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1355-13

Mixed Classification Biologics Event

Event ID64842
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross
CityBoise
StateID
CountryUS
Distribution PatternNevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana
 

Associated Products

Product DescriptionPlasma Frozen within 24 hours (FP24)
Code Info20GY55052; 20GY55090; 20GY55096; 20GY55097
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity4 units
Recall NumberB-1543-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info20GS49322; 20GS49377; 20GS49493; 20GS49495; 20GY55895; 20GY56039; 20GY55598; 20GY55610; 20FP12306; 20GS48814; 20GS49166; 20GH75559; 20GS48838; 20GS49245; 20GY55041; 20GY55126
ClassificationClass III
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity16 units
Recall NumberB-1544-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info20GS49322; 20GS49377; 20GS49493; 20GS49495; 20GY55895; 20GY56039; 20GY56426; 20FP12306; 20GH75559; 20GS48814; 20GS48838; 20GS49166; 20GS49245; 20GY55041; 20GY55052; 20GY55090; 20GY55096; 20GY55097; 20GY55126; 20GY55598; 20GY55610
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity21 units
Recall NumberB-1545-13
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