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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Class I Drugs Event

Event ID49085
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmChang Kwung Products
CityWoodland Hills
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
Code InfoNo lot codes are printed on the product
ClassificationClass I
Reason for RecallMarketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Product Quantity3,720 capsules total
Recall NumberD-833-2013
Product DescriptionLightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
Code InfoNo lot codes are printed on the product
ClassificationClass I
Reason for RecallMarketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Product Quantity3,720 capsules total
Recall NumberD-834-2013

Class I Drugs Event

Event ID64182
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmReumofan Plus USA
CitySpringfield
StatePA
CountryUS
Distribution PatternNationwide through internet sales.
 

Associated Products

Product DescriptionReumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
Code InfoLot #: 99515, Exp 09/2016
ClassificationClass I
Reason for RecallMarketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Product Quantity586 bottles
Recall NumberD-837-2013

Class I Veterinary Event

Event ID64539
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSteve's Real Food, Inc.
CityMurray
StateUT
CountryUS
Distribution PatternDistributed to four distributors in CA, TN, RI, and MN. No foreign, government, or military distribution.
 

Associated Products

Product DescriptionSteve's Real Food TURDUCKEN CANINE RECIPE, 5 lbs bags of 8 oz patties, UPC 6-91730-14204-9, Expiration 10/27/13, MFR # 83. Raw Frozen Dog Food, Distributed by Steve's Real Food Inc, Aumsville, OR 97086
Code InfoLot B209
ClassificationClass I
Reason for RecallSteve's Real Food is recalling certain lots of Turducken Canine Recipe due to possible salmonella contamination.
Product Quantity39 cases/156 bags
Recall NumberV-294-2013

Class I Veterinary Event

Event ID64726
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmJDJ Manufacturing, LLC
CityAumsville
StateOR
CountryUS
Distribution Patterndirectly distributed to California
 

Associated Products

Product DescriptionBARF Juicy Lamb Recipe contains 12 Lamb Patties per bag, 6 lbs. bag, 4 bags per case, sold under BARF brand name. The UPC is 8 37528 00104 8.
Code InfoLot 209. USE BY 7/27/2013.
ClassificationClass I
Reason for RecallBARF Juicy Lamb Recipe patties from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.
Product Quantity68 cases/4 bags/6 lbs.
Recall NumberV-290-2013
Product DescriptionBARF Juicy Combo Recipe Patties, 12 pieces per bag, 6 lbs. bag, 4 bags per case, sold under BARF brand name. The UPC is 8 37528 00106 2.
Code InfoLot 209. USE BY 7/27/2013.
ClassificationClass I
Reason for RecallBARF Juicy Combo Recipe patties from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.
Product Quantity42 cases/4 bags/6 lbs.
Recall NumberV-291-2013
Product DescriptionCombo Diet Bulk Pack 06306, 24 lbs. bag, sold under BARF brand name. There is no UPC for this item.
Code InfoLot 209. USE BY 07-27-13
ClassificationClass I
Reason for RecallCombo Bulk from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.
Product Quantity42 cases/24 lbs.
Recall NumberV-292-2013
Product DescriptionVariety Pack 04107, consists of one retail unit of BARF Combo, Beef, Chicken, and Lamb product. There are total 4 individual units per case. There is NO UPC for this product.
Code InfoLot 214. USE BY 08-01-13. Individual unit in this case bears LOT# T209, LOT# E212, LOt# E209, and LOT # T214.
ClassificationClass I
Reason for RecallVariety Pack from lot 214 sold under BARF brand are recalled due to a potential contamination with Salmonella.
Product Quantity199 cases/4 packs
Recall NumberV-293-2013

Class I Drugs Event

Event ID64792
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product Description0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Code InfoLot #: 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90
ClassificationClass I
Reason for RecallPresence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Product Quantity691,356 containers
Recall NumberD-836-2013

Class I Drugs Event

Event ID65196
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmApotex Corp.
CityWeston
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPiperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0
Code InfoLot No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, Exp. 04/14
ClassificationClass I
Reason for RecallCrystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Product Quantity52,398 vials
Recall NumberD-835-2013

Class I Drugs Event

Event ID65200
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-May-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmSandoz Incorporated
CityBroomfield
StateCO
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMethotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.
Code InfoLot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
ClassificationClass I
Reason for RecallPresence of Particulate Matter: Found during examination of retention samples.
Product Quantity1,635 vials
Recall NumberD-832-2013

Class I Drugs Event

Event ID65394
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZydus Pharmaceuticals USA Inc
CityPennington
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionWarfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
Code InfoLot MM5767
ClassificationClass I
Reason for RecallFailed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Product Quantity960 Bottles
Recall NumberD-838-2013

Class I Devices Event

Event ID65482
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCordis Corporation
CityMiami Lakes
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, Ny, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Hawaii and Puerto Rico and the countries of Canada & Panama
 

Associated Products

Product DescriptionCordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
Code InfoModel Numbers 466F220A and 466F220B.
ClassificationClass I
Reason for RecallCorrection to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Product Quantity33,000 units
Recall NumberZ-1887-2013

Class I Devices Event

Event ID65564
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCareFusion 303, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) and countries of: Australia, Canada and Europe.
 

Associated Products

Product DescriptionAlaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
Code Info1005435 10038007 1300550 3894703 1003149 19995706 3895887 19995118 1022500 1257000 1010235 3894799 1264612 1029800 10032389 3894714 3894796 1039450 19995610 3894886 1058150 1129100 1003197 1065900 3894701 10063252 1610200 1074200 3894708 10142044 1296030 1020387 3894811 1083900 10115320 1101500 1102400 1101601 10038966 19995620 3894841 1123000 1135600 1137240 1353400 3894860 1547000 1008565 1186900 6169100 10008460 3894844 1155500 3894711 10032361 10166465 3894702 10046069 10037661 10037647 3894834 3894836 10034261 1297400 1302600 1053000 1317801 3894817 3894797 10163092 10053161 1012161 3895854 10046578 1369040 1005333 1375900 10001956 3894734 3894789 3894833 10047157 1403100 1408700 10010196 3894892 3894765 1433251 1009496 1446000 1438800 1865900 1911872 10010570 19996156 10033408 1589480 1453703 1466600 1453702 6273300 10011620 1470203 1477201 1765300 1025650 10037131 19995384 1915200 1470204 1315403 10044246 1470001 1470202 19995746 6129700 1726300 1505700 10063253 10037742 1131700 10037723 4513601 1520101 1001799 10010451 4538200 10122836 1001783 1553400 1220200 3894705 1907800 1000456 6572500 19996529 10038213 3894830 1843701 10165568 1579040 10035744 10060127 3894819 3895895 1027700 1623400 1012793 10149088 3894849 1492500 1719500 10033426 1677100 1697501 1703300 6237701 1716400 1018653 10011474 1725100 1724300 1252400 6598300 1738700 6606300 10002540 19995700 10047163 1793108 3894718 1797801 10038591 1016746 1079000 1442503 19995670 10032641 1043750 1015768 1812600 1813200 1833900 1842600 1846801 1838401 1027503 1846000 10046982 10049664 10049674 10042072 10158492 10040131 1845700 3872400 3894825 3895883 3894801 3880600 3894722 3894716 3894723 3895875 3888400 6840950 10036536 3894870 1908600 1037000 1012361 19995045 10165422 10165005 10005354 10011455 1933600 3894735 1944700 980 500 10167738 111 10161003 10001154
ClassificationClass I
Reason for RecallCareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.
Product Quantity26,564 total units (26,220 units for US)
Recall NumberZ-1835-2013

Class I Devices Event

Event ID65689
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
 

Associated Products

Product DescriptionList No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14200-28; Lot Numbers: 022045H, 022055H, 030605H, 201765H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity672 units
Recall NumberZ-1850-2013
Product DescriptionList No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14203-28; Lot Numbers: 030895H, 961465H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity1,152 units
Recall NumberZ-1851-2013
Product DescriptionList No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14206-28; Lot Numbers: 020695H, 100865H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity1,976 units
Recall NumberZ-1852-2013
Product DescriptionList No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14207-28; Lot Number: 962295H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity240 units
Recall NumberZ-1853-2013
Product DescriptionList No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14210-28; Lot Number: 053835H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity96 units
Recall NumberZ-1854-2013
Product DescriptionList No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14211-28; Lot Numbers: 052945H, 211855H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity288 units
Recall NumberZ-1855-2013
Product DescriptionList No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14212-28; Lot Numbers: 030575H, 081425H, 090515H, 100905H, 100915H, 102255H, 102265H, 122515H, 122525H, 143405H, 143415H, 152655H, 152665H, 152675H, 161375H, 161385H, 161395H, 170955H, 172025H, 172035H, 172045H, 241805H, 250845H, 251735H, 251745H, 962235H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity692,742 units
Recall NumberZ-1856-2013
Product DescriptionList No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14217-28; Lot Number: 962255H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity1,104 units
Recall NumberZ-1857-2013
Product DescriptionList No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Code InfoList Number: 14219-28; Lot Number: 962245H
ClassificationClass I
Reason for RecallIt was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Product Quantity3,600 units
Recall NumberZ-1858-2013

Class I Food Event

Event ID65705
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOlde Thompson, Inc.
CityOxnard
StateCA
CountryUS
Distribution PatternUS states: " Connecticut " Delaware " Florida " Georgia " Maine " Maryland " Massachusetts " New Hampshire " New Jersey " New York " North Carolina " Ohio " Pennsylvania " Rhode Island " Virginia
 

Associated Products

Product DescriptionEarth's Pride Organics: Organic Oregano, 2.2 oz. Packaged at 12 units per case. Packaged in a glass jar with cork closure. Product labeling reads in part:"earth's pride organics PANTRY COLLECTION***ORGANIC OREGANO***NET WT. 2.2 OZ (62.4g)***DISTRIBUTED BY BJWC 25 RESEARCH DRIVE WESTBOROUGH, MA 01581 1-800-934-1204***".
Code InfoUPC code: 400000290942 Lot #: 060367, 060692, 061252 and 061864
ClassificationClass I
Reason for RecallOlde Thompson Inc. Oxnard, CA is recalling Earths Pride Organics: Organic Oregano packaged in a 2.2 oz. glass jar with cork closure, Lot #: 060367, 060692, 061252 and 061864 due to possible contamination by Salmonella.
Product Quantity11,000 UNITS
Recall NumberF-1793-2013

Class I Devices Event

Event ID65778
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmIradimed Corporation
CityWinter Park
StateFL
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denmark, Epsom, France, Germany, London, Netherlands, Saudia Arabia, and United Kingdom.
 

Associated Products

Product DescriptionMRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
Code InfoPart number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213.
ClassificationClass I
Reason for RecallThe Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.
Product Quantity176 individuals kits
Recall NumberZ-1874-2013

Class I Food Event

Event ID65860
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSuperior Nut Co. Inc.
CityCambridge
StateMA
CountryUS
Distribution PatternNationwide: AZ, AK, CA, CT, CO, DE, FL,HI, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, ND, NE, NH, NJ, NM, NL, NV, NY, OH, OK, PA, SC, SD, TN,TX, VA, WA, WV, WY Canada
 

Associated Products

Product DescriptionRaw Pistachio Halves, 1 pound bag. Item Number 11910, UPC Code: 172043119107; Raw Pistachio Halves, 4 pound bag. Item Number 11911, UPC Code: 172043119114; Raw Pistachio Halves, 10 pound bag in box. Item Number 11912, UPC Code: 172043119121; Raw Pistachio Halves, 25 pound case, bag in box. Item Number 11913, UPC Code: 172043119138
Code InfoLot 024413
ClassificationClass I
Reason for RecallPositive laboratory result for Salmonella sp. Speciation in progress.
Product Quantity120 - 1 pound units; 52 - 4 pound bags; 32 - 10 lb. cases; 23 - 25 pound units
Recall NumberF-1795-2013

Class I Food Event

Event ID65864
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPrimex Intl Trading Corp
CityLos Angeles
StateCA
CountryUS
Distribution PatternNJ and MA
 

Associated Products

Product DescriptionUS Pistachio Shelled, Halves, Raw, Net Weight: 30lbs.
Code InfoLot#T0010092, expiry date: September 2014
ClassificationClass I
Reason for RecallPrimex International Trading Corp. is recalling Pistachios Shelled, Halves, because it has the potential to be contaminated with Salmonella.
Product Quantity477 units (14,310 lbs)
Recall NumberF-1794-2013

Class II Biologics Event

Event ID35757
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoLF32600
ClassificationClass II
Reason for RecallBlood product, for which the quality control testing for red blood cell volume was not performed, was distributed.
Product Quantity1 unit
Recall NumberB-1966-13

Class II Biologics Event

Event ID38569
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoFZ77035
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-1925-13

Class II Biologics Event

Event ID38570
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoFZ85617
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-1924-13

Class II Biologics Event

Event ID38571
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoGW97725
ClassificationClass II
Reason for RecallBlood product, which may have been out of controlled storage for greater than 30 minutes, was distributed.
Product Quantity1 unit
Recall NumberB-1965-13

Class II Biologics Event

Event ID38572
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoFZ80940, FZ84236
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity2 units
Recall NumberB-1923-13

Class II Biologics Event

Event ID38777
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityLouisville
StateKY
CountryUS
Distribution PatternKY
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced.
Code Info24FP04503; 24FP04503
ClassificationClass II
Reason for RecallBlood products, held in quarantine pending results of an investigation, were distributed
Product Quantity2 components
Recall NumberB-1920-13

Class II Biologics Event

Event ID38780
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-07
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma
CityDayton
StateOH
CountryUS
Distribution PatternGermany, Ilinios
 

Associated Products

Product DescriptionSource Plasma
Code Info4080095992, 4080114685, 4080107999, 4080106384, 4080105847, 4080098437, 4080096586
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity7 units
Recall NumberB-1564-13

Class II Biologics Event

Event ID38781
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-07
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma
CityDayton
StateOH
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info4080141558, 4080140651, 4080140149, 4080127236, 4080125772, 4080124313, 4080123731
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity7 units
Recall NumberB-1957-13

Class II Biologics Event

Event ID38800
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityCleveland
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info042K90931
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1958-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info042K90931 (pool 1997)
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1959-13
Product DescriptionPlasma Frozen
Code Info042K90931
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1960-13

Class II Biologics Event

Event ID39200
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-07
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBioLife Plasma Services L.P.
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info07RMIB5916
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported post donation information regarding IV drug use, was distributed.
Product Quantity1
Recall NumberB-1919-13

Class II Biologics Event

Event ID39760
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCentral Kentucky Blood Center, Inc.
CityLexington
StateKY
CountryUS
Distribution PatternKentucky
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info2069982
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed
Product Quantity1 unit
Recall NumberB-1917-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info2086318; 1998668; 2019185; 2024609
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed
Product Quantity4 units
Recall NumberB-1918-13

Class II Biologics Event

Event ID40144
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPresbyterian Intercommunity Hospital, Inc. Blood Bank
CityWhittier
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Irradiated
Code Info P57203
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-2031-13
Product DescriptionFresh Frozen Plasma.
Code Info P57203
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-2032-13

Class II Biologics Event

Event ID40408
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jun-04
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternPoway, California and Escondido, California
 

Associated Products

Product DescriptionRed Blood Cells
Code Info06GY28769; 06GY28770
ClassificationClass II
Reason for RecallBlood products, tested for communicable diseases using unsuitable samples, were distributed.
Product Quantity2
Recall NumberB-1675-13

Class II Biologics Event

Event ID41384
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Nov-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityCleveland
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info042E48603
ClassificationClass II
Reason for RecallBlood products, which did not undergo the required quality control testing, were distributed.
Product Quantity2 components
Recall NumberB-1916-13

Class II Biologics Event

Event ID41626
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Oct-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info05RCAB4721
ClassificationClass II
Reason for RecallBlood product, which was not quarantined after receiving information regarding the donor's contact with a person who tested reactive for HBsAg, was distributed.
Product Quantity1 unit
Recall NumberB-1927-13

Class II Biologics Event

Event ID42701
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBioLife Plasma Services L.P.
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info06SUTA7770, 06SUTA7236, 06SUTA6923
ClassificationClass II
Reason for RecallBlood products, which were not quarantined after receiving information regarding a risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity3 units
Recall NumberB-1926-13

Class II Biologics Event

Event ID43171
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-May-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPresbyterian Intercommunity Hospital, Inc. Blood Bank
CityWhittier
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info3594412
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-2033-13

Class II Biologics Event

Event ID44234
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityToledo
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info50KW03215
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 components
Recall NumberB-1910-13

Class II Biologics Event

Event ID45179
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHemaCare Corporation
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoFS14433
ClassificationClass II
Reason for RecallBlood product, collected from a donor during a one year period of deferral for travel to a malarial endemic area.
Product Quantity1
Recall NumberB-1503-13

Class II Biologics Event

Event ID47622
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Apr-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoGZ11666; GZ11666
ClassificationClass II
Reason for RecallBlood products, quality control and distribution of products which did not meet specifications, were distributed. .
Product Quantity2 units
Recall NumberB-1895-13

Class II Biologics Event

Event ID48388
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia, Arizona, Washington DC
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code Info06FS23078 , 06LF90461,
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2067-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info06FM42146, 06FM42698,
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2068-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info06LC12397, 06LK96510, 06LQ82947, 06FP66382, 06GS22086, 06GV57858, 06LQ83398, 06GW37271, 06GF50169, 06GE22291, 06GS23145, 06LF92077, 06GF51447, 084FT13509, 084J 21960, 084KM77737, 084T48723, 084T49156, 07FC33547, 07GT00491, 07GJ28906, 07FJ97037, 07FY72624,06FT00807, 06LE43292, 06FT01385, 06FE13059, 06FM42146, 084K00268, 07FC33546
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed..
Product Quantity30
Recall NumberB-2069-13
Product DescriptionCryoprecipitated AHF
Code Info06FS23078, 06FP66382, 06GW37271, 06GS23145,
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity4 units
Recall NumberB-2070-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info06KR54131, 06KR54178, 06KR54290,06KG50494, 06KR54131, 06KR54178, 06KR54290,
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity7 units
Recall NumberB-2071-13
Product Description Plasma Cryoprecipitate Poor Reduced
Code Info06GW37271,06GS23145, 084K00351,
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-2072-13
Product Description Plasma Frozen within 24 hours
Code Info 06LK96510, 06LE43292, 06GV57858, 06GF50169, 06FE13059, 084FT13509, 07FY72624, 06LQ82947,06FM42146,06GE22291, 084J 21960, 084KM77737, 084K00268, 07FC33546,07FJ97037,
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity15
Recall NumberB-2073-13
Product DescriptionRecovered Plasma
Code Info06KG50494, 06KR54131, 06KR54178,06KR54290, 06GS22086, 06LQ83398,084T48723, 084T49156, 07GT00491,07GJ28906,
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity10 units
Recall NumberB-2074-13

Class II Biologics Event

Event ID48525
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBioLife Plasma Services L.P.
CityVan Nuys
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info07SWIC5381
ClassificationClass II
Reason for RecallBlood product, which was not quarantined subsequent to receiving information regarding a post donation information, was distributed.
Product Quantity1
Recall NumberB-2065-13

Class II Biologics Event

Event ID48869
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info07FY74209
ClassificationClass II
Reason for RecallBlood product, in which donor gave history which warranted deferral or follow up questions was not asked, was distributed.
Product Quantity1 unit
Recall NumberB-2035-13

Class II Biologics Event

Event ID50246
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CityPhoenix
StateAZ
CountryUS
Distribution PatternCA, Spain
 

Associated Products

Product DescriptionSource Plasma
Code Info0230303925 0230288437 0230286392 0230264093 0230263403 0230262523 0230227677 0230217519 0230216931 0230215526 0230213763 0230213156 0230212633 0230211886 0230210832 0230205537 0230203735 0230202941 0230202048 0230201656 0230184950 0230184135
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity22 units
Recall NumberB-2038-13

Class II Biologics Event

Event ID53631
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Aug-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info6240281727, 6240279727, 6240279034, 6240276220, 6240274982, 6240269240, 6240268017, 6240265756, 6240263938, 6240261729, 6240260270, 6240258649, 6240257869, 6240255932, 6240255078, 6240253287, 6240252535, 6240250203, 6240249354, 6240247835, 6240246792, 6240245034, 6240244209, 6240242549, 6240241771, 6240240130, 6240239304
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity27 units
Recall NumberB-2030-13

Class II Biologics Event

Event ID59132
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Apr-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMO; TX; AR; NC; TN; OH; MS;
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW045110210942; W045110203566; W045111231320; W045110199254; W045110209874; W045110209932; W045110213116; W045110193473; W045110218893; W045110216742; W045110222062; W045111228903; W045111232508; W045111245749; W045111228354; W045111240957; W045111235642; W045111240428; W045110218213; W045111240860; W045111245139; W045110222102
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity22 Units
Recall NumberB-1884-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045110198384; W045111231311; W045111235643; W045110213388; W045110202176; W045110200571; W045110213387; W045111231336; W045111228340; W045111241714; W045110202805; W045110208558; W045110211561; W045110193447; W045110208176; W045110198517; W045110198671; W045110198484; W045110213121; W045110211930; W045110198834; W045110198841; W045110199767; W045110198553; W045110198519; W045110198666; W045110202815; W045110198445; W045110203531; W045110199174; W045110203569; W045110203557; W045110209301; W045110209333; W045110208572; W045110208591; W045110208563; W045110209870; W045110213140; W045110203742; W045110205970; W045110199773; W045110200191; W045110200227; W045110198504; W045110198571; W045110198637; W045110198383; W045110202822; W045110202829; W045110198451; W045110198483; W045110198472; W045110198473; W045110198464; W045110205948; W045110203050; W045110205954; W045110205939; W045110203523; W045110203604; W045110209337; W045110209331; W045110209156; W045110188078; W045110188079; W045110209903; W045110208175; W045110203685; W045110203711; W045110213108; W045110188237; W045110188235; W045110218004; W045110214486; W045110198711; W045110205874; W045110203061; W045110208562; W045110214184; W045110203603; W045110200226; W045110202178; W045110202200; W045110202164; W045110198622; W045110198381; W045110198461; W045110198481; W045110205886; W045110203590; W045110203564; W045110209299; W045110209170; W045110208601; W045110208631; W045110209760; W045110209940; W045110209915; W045110203708; W045110213169; W045110211935; W045110188230; W045110188218; W045110214225; W045110213775; W045110198614; W045110198713; W045110203563; W045110203591; W045110211604; W045110203734; W045110203730; W045110214447; W045110198369; W045110199203; W045110208181; W045110203694; W045110214228; W045110214441; W045110200142; W045110210750; W045110188221; W045110203585; W045110218019; W045110198567; W045110198608; W045110198626; W045110198707; W045110198456; W045110209154; W045110188231; W045110209305; W045110209864; W045110208179; W045110213137; W045110198278; W045110200146; W045110198631; W045110198639; W045110209353; W045110209794; W045110214470; W045110199758; W045110198303; W045110202186; W045110202157; W045110198595; W045110202813; W045110202806; W045110198466; W045110205983; W045110203137; W045110203519; W045110199178; W045110199189; W045110199181; W045110208627; W045110188089; W045110209816; W045110209947; W045110203654; W045110203662; W045110203657; W045110203668; W045110203727; W045110213174; W045110213187; W045110211938; W045110211922; W045110211917; W045110188238; W045110193495; W045110198301; W045110198212; W045110200202; W045110198562; W045110198670; W045110198374; W045110198448; W045110203148; W045110205924; W045110203117; W045110199196; W045110203599; W045110203577; W045110209507; W045110188072; W045110188100; W045110188098; W045110209834; W045110203664; W045110211515; W045110211608; W045110211567; W045110203700; W045110203692; W045110203689; W045110213145; W045110203746; W045110210756; W045110218012; W045110214481; W045110214476; W045110198859; W045110202112; W045110198364; W045110188086; W045110203691; W045110218003; W045110198849; W045110198293; W045110202221; W045110199200; W045110208188; W045110211513; W045110214226; W045110200183; W045110198513; W045110202824; W045110198459; W045110198475; W045110203039; W045110209212; W045110188090; W045110209825; W045110209799; W045110209768; W045110209820; W045110209841; W045110211510; W045110188233; W045110218011; W045110214195; W045110216934; W045111240869; W045111243170; W045111242964; W045111229365; W045111231079; W045111233036; W045111233048; W045111247591; W045111244256; W045111244270; W045111248235; W045110210659; W045110210666; W045111240421; W045111243198; W045110218220; W045110219147; W045110219101; W045110219090; W045110219217; W045110218885; W045110210603; W045111228062; W045111229367; W045111229353; W045111229371; W045111229357; W045111224033; W045111232155; W045111231101; W045111233776; W045111233757; W045111233941; W045111233997; W045111232619; W045111233277; W045111240420; W045111240863; W045111241679; W045111234965; W045111234996; W045111243775; W045111243779; W045111244092; W045111234352; W045111245056; W045111245175; W045111247542; W045111247619; W045111233246; W045111233249; W045111248013; W045111248370; W045111248394; W045111248522; W045111247463; W045110216928; W045111248375; W045110218217; W045110200612; W045110219133; W045110219137; W045110219142; W045110219207; W045110219164; W045110218862; W045110218884; W045110218858; W045110218888; W045110210938; W045110210941; W045110215120; W045110216273; W045110213457; W045110216740; W045110210656; W045110222052; W045110222116; W045111227281; W045111227288; W045111231316; W045111231324; W045111228899; W045111232147; W045111232136; W045111225190; W045111233764; W045111232593; W045111233326; W045111233372; W045111230749; W045111232272; W045111232264; W045111240365; W045111240491; W045111240359; W045111240886; W045111240898; W045111240943; W045111240912; W045111240936; W045111241721; W045111234999; W045111243756; W045111243753; W045111243767; W045111243776; W045111235577; W045111235628; W045111244102; W045111244052; W045111244022; W045111244096; W045111234309; W045111234324; W045111234463; W045111243090; W045111234468; W045111244271; W045111245705; W045111248585; W045111247461; W045111249118; W045111230747; W045111231323; W045111231310; W045110220275; W045110215121; W045111233256; W045111231315; W045111230538; W045110222097; W045111231322; W045111231086; W045111233851; W045110203464; W045110218238; W045110219174; W045110218881; W045110215119; W045110213394; W045110213380; W045110218966; W045110222044; W045111228060; W045111228712; W045111228736; W045111228733; W045111227968; W045111233315; W045111233352; W045111233385; W045111240884; W045111240951; W045111241284; W045111241698; W045111241696; W045111234979; W045111234963; W045111243774; W045111243771; W045111244063; W045111244127; W045111244117; W045111234362; W045111243066; W045111245060; W045111245027; W045111245191; W045111245657; W045111248398; W045111248560; W045110216733; W045110215109; W045110216915; W045110216976; W045110218970; W045111228034; W045111228730; W045111228323; W045111233769; W045111233828; W045111233888; W045111240816; W045111240819; W045111241724; W045111235625; W045111234396; W045110200597; W045110219150; W045110213391; W045111228793; W045111228885; W045111227967; W045111231132; W045111233761; W045111233766; W045111233955; W045111233388; W045111240858; W045111240854; W045110216720; W045110216748; W045111231319; W045111231318; W045111228748; W045111248525; W045111234260; W045110219225; W045110215101; W045110216287; W045111233944; W045110219117; W045110220269; W045110218871; W045110218867; W045110213399; W045110210604; W045111228250; W045111227963; W045111232672; W045111232665; W045111233282; W045111229475; W045111240486; W045111241719; W045111244133; W045111245698; W045111248578; W045111250951; W045110200602; W045111229356; W045111225167; W045111233774; W045111233760; W045111233772; W045111233858; W045111233790; W045111233811; W045111233902; W045111240438; W045111234273; W045111234386; W045111245176; W045111247500; W045111245717; W045110203462; W045110220278; W045110216721; W045110216936; W045111228051; W045111232138; W045111232139; W045111225173; W045111225180; W045111233866; W045111232195; W045111233038; W045111233046; W045111242989; W045111243176; W045111245133; W045111248016; W045111248587; W045111240350; W045111243037; W045110218228; W045110219223; W045110210950; W045110210939; W045110215112; W045110213390; W045110213389; W045110210615; W045110210660; W045110216938; W045110216972; W045110222087; W045111228799; W045111228900; W045111228882; W045111227969; W045111232126; W045111225201; W045111231109; W045111231098; W045111232552; W045111232617; W045111233253; W045111232692; W045111229495; W045111229468; W045111229487; W045111240917; W045111243759; W045111235627; W045111244153; W045111234330; W045111234364; W045111234308; W045111247545; W045111247555; W045111247539; W045111245685; W045111248249; W045111249870; W045110203461; W045110203469; W045110218231; W045110218236; W045110200665; W045110200656; W045110200646; W045110219155; W045110215111; W045110215098; W045110216275; W045110213379; W045110210607; W045110213443; W045110213458; W045110216726; W045110210664; W045110210671; W045110222050; W045111227290; W045111231333; W045111231306; W045111231312; W045111231325; W045111228253; W045111228738; W045111228878; W045111228881; W045111228897; W045111227961; W045111228351; W045111229911; W045111232134; W045111232153; W045111225176; W045111231077; W045111232524; W045111232567; W045111233272; W045111232703; W045111232747; W045111232194; W045111232188; W045111229497; W045111232261; W045111234985; W045111234980; W045111234984; W045111243768; W045111244124; W045111243040; W045111234379; W045111243190; W045111245187; W045111247586; W045111245745; W045111245400; W045111248386; W045111248389; W045111248404; W045111248241; W045111248232; W045111247171; W045110219118; W045110219088; W045110216290; W045110213441; W045111227286; W045111227283; W045111232526; W045111233784; W045111232623; W045111232584; W045111232200; W045111233002; W045111229483; W045111232252; W045111241293; W045111243755; W045111235580; W045111245020; W045111245124; W045111245417; W045111245406; W045111245741; W045111248406; W045111234406; W045110210605; W045110222033; W045111228895; W045111233367; W045111241684; W045110203467; W045111244089; W045110213397; W045110213383; W045111227966; W045111227978; W045111224043; W045111232146; W045111241717; W045110200589; W045110219177; W045110210954; W045110213393; W045111228038; W045111228041; W045111227972; W045111229346; W045111229352; W045111225165; W045111232679; W045111232191; W045111240342; W045111233043; W045111233034; W045111241288; W045111241309; W045111234967; W045111235576; W045111235632; W045111244156; W045111244171; W045111244122; W045111234269; W045111234265; W045111245647; W045111245697
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity670 Units
Recall NumberB-1885-13
Product DescriptionPlasma Frozen within 24 hours
Code InfoW045110218862; W045110218228; W045110219150; W045110219133; W045110210656; W045111228041; W045111229352; W045111229346; W045111229357; W045111225190; W045111231079; W045111233272; W045111232665; W045110218231; W045110200646; W045110218881; W045110218871; W045110213441; W045111224033; W045111225176; W045111233944; W045111232672; W045111233256; W045110200597; W045110210605; W045111228038; W045111232153; W045111243753; W045111234996; W045111234965; W045110218220; W045110219117; W045110220269; W045110220275; W045110218888; W045110210954; W045110213390; W045110213380; W045110213399; W045111232147; W045111232146; W045111231101; W045111233997; W045111233034; W045111233048; W045111243759; W045111243767; W045110218217; W045110218885; W045110210950; W045110216721; W045110222097; W045110222102; W045111231077; W045111231132; W045111233774; W045111233277; W045111232692; W045111233253; W045111240428; W045110219137; W045110218884; W045110218893; W045110213393; W045110210615; W045110210666; W045110218970; W045111227286; W045110198849; W045110202805; W045110198475; W045110198484; W045110203117; W045110203137; W045110209903; W045110209834; W045110203727; W045110214447; W045110200142; W045110198483; W045110199767; W045110198364; W045110209301; W045110208591; W045110208631; W045110209864; W045110213775; W045110198504; W045110208572; W045110208563; W045110198834; W045110198859; W045110198513; W045110198614; W045110198713; W045110198639; W045110198637; W045110198711; W045110202815; W045110198473; W045110203604; W045110211604; W045110211608; W045110203730; W045110211930; W045110214470; W045110198595; W045110198517; W045110202813; W045110205954; W045110203039; W045110199181; W045110208558; W045110203664; W045110213145; W045110213174; W045110213140; W045110198293; W045110199773; W045110198567; W045110198553; W045110198381;W045110198369; W045110198451; W045110205970; W045110205886; W045110211917; W045110203746; W045110193495; W045110211938
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity130 Units
Recall NumberB-1886-13
Product DescriptionPlasma Cryoprecipitate Reduced
Code InfoW045110211561
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity1 Unit
Recall NumberB-1887-13
Product DescriptionCryoprecipitated AHF
Code InfoW045110216936; W045110216976; W045110216972; W045110222052; W045110222044; W045111228051; W045111228062; W045110222050; W045110222062; W045110213116; W045110216287; W045110222033; W045110200227; W045110203577; W045110203564; W045110211561; W045110210939; W045110216275; W045110216748; W045110216915; W045111228060; W045111240917
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity22 Units
Recall NumberB-1888-13

Class II Devices Event

Event ID63187
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmArjo, Inc. dba ArjoHuntleigh
CityAddison
StateIL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen.
 

Associated Products

Product DescriptionEnterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
Code InfoModels 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers
ClassificationClass II
Reason for RecallArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.
Product Quantity94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW
Recall NumberZ-0476-2013
Product DescriptionEnterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
Code InfoModels 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers
ClassificationClass II
Reason for RecallArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.
Product Quantity1,324 beds in USA, 138 beds in Canada, 1,877 beds ROW
Recall NumberZ-0477-2013

Class II Devices Event

Event ID63605
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, and Canada
 

Associated Products

Product DescriptionBeckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
Code InfoModels, Catalogue Numbers: AU5811-01, A94906; AU5811-02, A94907; AU5811-03, A94908; AU5811-04, A94909; AU5811-06, A94910; AU5821-01, A94911; AU5821-02, A94912; AU5821-03, A94913; AU5821-04, A94914; AU5821-06, A94915; AU5831-01, A94916; AU5831-02, A94917; AU5831-03, A94918; AU5831-04 A94919; AU5831-06 A94920; AU5831-01 A94921; AU5831-02 A94922; AU5831-03 A94923; AU5831-04 A94924; AU5831-06 A94925.
ClassificationClass II
Reason for RecallBeckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.
Product Quantity338 units (11 units in the US)
Recall NumberZ-1873-2013

Class II Devices Event

Event ID64244
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVentana Medical Systems Inc
CityOro Valley
StateAZ
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and country of: Germany.
 

Associated Products

Product DescriptionVENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
Code InfoCat#750-600; PN 05342716001; Serial #'s: 310724, 310735, 311187, 312055, 310373, 311052, 311171, 311953, 310750, 311266, 311267, 311564, 311565, 311596, 311304, 310481, 311924, 310607, 311627, 310527, 311436, 311742, 310132, 311432, 310034, 310408, 310687, 310697, 311343, 311958, 310728, 310778, 311991, 312070, 310471, 311326, 311952, 310103, 310777, 311446, 310924, 311303, 311528, 310490, 310913, 311529, 311494, 310139, 310281, 310465, 310275, 310617, 310665, 310716, 311853, 311871, 312137, 312101, 310240, 310237,310238, 311571, 311404, 310356, 310023, 312164, 312165, 310065, 310231, 310711, 310706, 310707, 310703, 311509, 310330, 310633, 311811, 311810, 310977, 311194, 311198, 310208, 310732, 310740, 310187, 311462, 311935, 310145, 311037, 310346, 310585, 310694, 310699, 310701, 310702, 310705, 310709, 310710, 310704, 311106, 311110, 311111, 311419, 311484, 311527, 310345, 311381, 311353, 310480, 311869, 311921, 311458, 310315, 310412, 311988, 310618, 310397, 310399, 311868, 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310224, 311033, 312076, 312078, 312090, 310632, 312116, 310751, 310249, 311468, 310923, 310123, 311760, 310180, 311160, 310905, 310605, 310458, 311925, 310822, 311485, 311503, 311500, 311474, 310879, 312061, 310189, 310191, 312039, 312051, 312052, 312059, 312188, 311948, 311072, 310182, 310503, 310922, 311172, 311461, 311324, 311209, 310799, 310807, 310314, 310855, 312127, 310084, 310165, 311322, 311321, 310573, 310572, 311559, 310375, 310181, 310308, 312103, 312077, 312106, 312107, 312108, 310474, 310486, 312021, 312167, 312169, 311247, 310634, 310461, 312203, 310730, 310729, 311065, 311348, 311346, 311332, 310763, 312126, 310036, 310348, 310362, 311395, 311459, 311472, 311236, 311450, 311451, 310884, 311118, 311887, 311337, 311338, 310842, 310028, 310318, 310479, 311773, 311259, 311679, 312009, 312012, 310283, 310453, 310501, 310663, 310889, 310715, 311482, 311183, 311184, 310610, 311520, 311506, 310369, 310770, 310351, 310827, 310497, 311006, 311399, 311040, 311355, 312132, 312133, 311510, 310410, 312088, 311407, 310043, 310044, 310045, 310818, 310085, 311120, 311918, 311989, 311117, 310179, 311105, 311049, 312176, 310099, 311563, 310100, 310190, 311823, 310058, 310061, 310864, 311389, 310805, 310048, 311911, 311425, 311146, 310228, 310260, 311534, 310736, 310738, 310722, 311223, 310128, 310137, 310059, 312140, 311471, 311519, 310831, 310120, 311307, 310806, 311902, 310319, 311798, 311802, 312129, 312130, 311076, 311139, 311132, 311181, 311496, 311507, 312147, 312154, 310762, 310447, 311168, 310466, 311619, 311617, 310451, 311415, 311756, 312048, 311149, 310892, 311488, 311491, 311238, 311531, 311801, 311898, 311934, 310101, 310142, 311532, 311317, 311341, 310637, 311310, 311237, 310880, 311420, 312053, 311940, 311941, 311951, 311467, 310209, 310817, 311708, 310413, 311755, 310462, 310464, 311927, 311697, 310354, 312057, 311041, 311115, 311492, 311441, 310195, 310125, 310194, 310223, 310222, 310279, 310469, 310795, 310326, 311502, 311192, 311039, 311051, 311385, 310405, 311764, 310850, 311413, 310825, 310743, 310744, 310785, 310801, 310802, 310280, 310303, 311251, 311406, 311200, 311333, 310401, 311271, 310325, 311920, 310793, 310684, 310068, 311262, 311264, 310109, 311161, 311487, 312119, 311834, 311950, 311729, 311437, 311444, 312054, 311053, 311046, 311193, 310649, 310392, 311860, 310409, 312120, 312121, 311104, 311892, 310812, 310996, 310556, 311936, 310739, 311677, 312064, 312065, 312110, 312113, 310883, 311907, 311945, 310639, 311900, 310564, 311522, 311535, 311239, 311240, 310809, 311296, 311843, 311454, 311480, 310476, 312095, 311997, 311820, 310566, 311784, 311258, 310192, 310758, 311818, 311899, 311201, 311382, 310843, 310733, 310734, 311712, 311440, 311150, 310937, 310737, 310680, 310829, 311430, 310609, 310741, 311246, 311253, 311342, 310545, 310568, 311699, 311698, 310939, 310942, 310496, 310907, 311909, 310692, 310926, 310534, 311269, 310838, 310327, 311852, 312111, 310891, 310062, 310172, 310834, 310463, 310502, 310914, 311944, 311021, 310316, 311695, 311703, 311805, 311806, 311807, 311809, 312003,311005, 310885, 311752, 311751, 311732, 312150, 311942, 312026, 310676, 310225, 310353, 310473, 310475, 311508, 310717, 311089, 311148, 311138, 311140, 311141, 311320, 310454, 312143, 310593, 310591, 310657, 312081, 312125, 310226, 310611, 311349, 312151, 310322, 310064, 310748, 310216, 310494, 310495, 311029, 310217, 312016, 311775, 311777, 310443, 310597, 310603, 310602, 310606, 310360, 310130, 310131, 310133, 310143, 311178, 310138, 310140, 310276, 311792, 311504, 311501, 311499, 310411, 310621, 310690, 310727, 311249, 311288, 311400, 311418, 311457, 311470, 311696, 311694, 311693, 311309, 310040, 310681, 310823, 310798, 311056, 310416, 311408, 311344, 311906, 311624, 312017, 312033, 311943, 311048, 311409, 311495, 311758, 311093, 311447, 311885, 310367, 311489, 310352, 311975, 311977, 311339, 310376, 310379, 311653, 311199, 310385, 310414, 310485, 311260, 310244, 311365, 311366, 310324, 310033, 310304, 312010, 312011, 310918, 310919, 312007, 310156, 310819, 311765, 311490, 311351, 311063, 310899, 310903, 311022, 311025, 311088, 310660, 311274, 312146, 310027, 310909, 311922, 310134, 310041, 310232, 310613, 311497, 312062, 311575, 311740, 311970, 310538, 310644, 310873, 311822, 311536, 311980, 310188, 310574, 311383, 310925, 310958, 310960, 311030, 311019, 311179, 311180, 310121, 311087, 310877, 310449, 310450, 310487, 311515, 311427, 311516, 311452, 310219, 310239, 312203 All serial numbers in the market
ClassificationClass II
Reason for RecallPotiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component.
Product Quantity1735 instruments
Recall NumberZ-0833-2013
Product DescriptionVENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
Code InfoCat#750-601; PN 05987750001; Serial #'s: 310646, 311573, 310477, 311725, 311042, 311623, 312032, 312159, 310615, 310837, 311862, 311043 311572, 311766, 310526, 311011, 311185, 311723, 312082, 310635, 311574, 312084, 310636, 310835, 311179, 310493, 311183, 311769, 311930, 311962, 311963, 310437, 311965, 310997, 311726, 311620, 311512, 311526, 312083, 310468, 310759 (All serial numbers in the market).
ClassificationClass II
Reason for RecallPotential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component.
Product Quantity54 instruments
Recall NumberZ-0834-2013

Class II Biologics Event

Event ID64554
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA, IN
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128712240529
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-2040-13

Class II Devices Event

Event ID64984
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternDistribution only in Texas.
 

Associated Products

Product DescriptionRev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .
Code InfoLot Number: PM3979
ClassificationClass II
Reason for RecallInserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.
Product Quantity8
Recall NumberZ-1926-2013

Class II Devices Event

Event ID64985
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternUS Distribution including Puerto Rico and the states of CO, KS, MA and TX.
 

Associated Products

Product DescriptionDrill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Code Info2520301, 2520307
ClassificationClass II
Reason for RecallPrior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
Product Quantity13 drill guides
Recall NumberZ-1871-2013

Class II Devices Event

Event ID64993
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternUS Distribution including the states of MA, NV and TX.
 

Associated Products

Product DescriptionT-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Code InfoLot Numbers: 1335201A, 1446101A
ClassificationClass II
Reason for RecallDuring an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Product Quantity11
Recall NumberZ-1932-2013

Class II Devices Event

Event ID65152
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternNationwide distribution: US including states of : AK, AL, AR, AZ, CA, CO, CT, DC, GA, GU, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
 

Associated Products

Product DescriptionDimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.
Code InfoProduct - MMB CAL, Catalog Number RC420, Siemens Material Number 10445023 with lot numbers 2GD053, 2KD024, and 3AD051.
ClassificationClass II
Reason for RecallSiemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.
Product Quantity7,470
Recall NumberZ-1925-2013

Class II Biologics Event

Event ID65156
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmOneBlood, Inc. dba Southeastern Comm. Blood Center
CityTallahassee
StateFL
CountryUS
Distribution PatternFlorida; Georgia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW12701380967900; W12701380967700; W12701380968200; W12701380950700; W12701380953600; W12701380953400; W12701380953300; W12701380953700; W12701380953800; W12701381096600; W12701381096400; W12701380957500; W12701380705400; W12701380706400; W12701380706000; W12701380705100; W12701380706600; W12701380706100; W12701380707000; W12701380707400; W12701381054200; W12701381052100; W12701381053700; W12701381055400; W12701381052600; W12701381052400; W12701381054500; W12701381051700; W12701380719000; W12701380718200;
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the products, were distributed.
Product Quantity30 units
Recall NumberB-1939-13

Class II Devices Event

Event ID65162
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc
CityEast Walpole
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.
 

Associated Products

Product DescriptionADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Code InfoPer recall strategy.
ClassificationClass II
Reason for RecallA rare variant of TSH, identified in a small cluster of patients, is not detected.
Product Quantity172913
Recall NumberZ-1881-2013
Product DescriptionDimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Code InfoPer recall strategy.
ClassificationClass II
Reason for RecallA rare variant of TSH, identified in a small cluster of patients, is not detected.
Product Quantity39763
Recall NumberZ-1882-2013
Product DescriptionDimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Code InfoPer recall strategy.
ClassificationClass II
Reason for RecallA rare variant of TSH, identified in a small cluster of patients, is not detected.
Product Quantity33506
Recall NumberZ-1883-2013
Product DescriptionDimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Code InfoPer recall strategy.
ClassificationClass II
Reason for RecallA rare variant of TSH, identified in a small cluster of patients, is not detected.
Product Quantity18584
Recall NumberZ-1884-2013
Product DescriptionIMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Code InfoPer recall strategy.
ClassificationClass II
Reason for RecallA rare variant of TSH, identified in a small cluster of patients, is not detected.
Product Quantity51792
Recall NumberZ-1885-2013
Product DescriptionIMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Code InfoPer recall strategy.
ClassificationClass II
Reason for RecallA rare variant of TSH, identified in a small cluster of patients, is not detected.
Product Quantity13462
Recall NumberZ-1886-2013

Class II Biologics Event

Event ID65280
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDCI Donor Services dba Sierra Donor Services
CitySacramento
StateCA
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionCornea
Code InfoSDS130600OSCN; SDS130600ODCN
ClassificationClass II
Reason for RecallCorneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 units
Recall NumberB-2025-13

Class II Drugs Event

Event ID65300
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira, Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionOndansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Code InfoLot 25394DK, exp. 01/2015
ClassificationClass II
Reason for RecallPresence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Product Quantity340,600 vials
Recall NumberD-851-2013

Class II Devices Event

Event ID65322
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Company
CityFranklin Lakes
StateNJ
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionBD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
Code InfoMarketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.
ClassificationClass II
Reason for RecallBD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.
Product Quantity37,906,400 units
Recall NumberZ-1923-2013

Class II Devices Event

Event ID65370
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSmith & Nephew Inc
CityMemphis
StateTN
CountryUS
Distribution PatternWorldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.
 

Associated Products

Product DescriptionR3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
Code InfoBatch No. 12FM00603
ClassificationClass II
Reason for RecallOne batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
Product Quantity53 units
Recall NumberZ-1928-2013
Product DescriptionR3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
Code InfoBatch No. 12FM00602
ClassificationClass II
Reason for RecallOne batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
Product Quantity53 units
Recall NumberZ-1929-2013

Class II Drugs Event

Event ID65422
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNovartis Consumer Health
CityLincoln
StateNE
CountryUS
Distribution PatternNationwide, Puerto Rico, Brazil and Panama
 

Associated Products

Product DescriptionExcedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.
Code InfoLot #s a) 10120190, Exp 6/13 and 10121628, Exp 7/13; Lot #s b) 10115658, Exp 5/13; 10116807, Exp 5/13; 10121630, Exp 7/13 and 10125253, Exp 9/13 Foreign Lot #s c) 10120192, Exp 7/13; d)10120272, Exp 7/13, 10121528 Exp 7/13 and 10121958 Exp 8/13
ClassificationClass II
Reason for RecallDefective container: products are packaged in pouches which may not have been fully sealed
Product Quantitya) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)
Recall NumberD-843-2013
Product DescriptionExcedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers
Code InfoLot # a) 10116809, Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228 Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13
ClassificationClass II
Reason for RecallDefective container: products are packaged in pouches which may not have been fully sealed
Product Quantity10,624,000 pouches
Recall NumberD-844-2013
Product DescriptionNo Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02
Code InfoLot #s 10110263, Exp 2/14; 10114706, Exp 4/14; 10118209, Exp 5/14; 10120253, Exp 7/14; 10123520, Exp 8/14; 10095199, Exp 7/13; 10102536, 11/2013, 10103950, Exp 12/13
ClassificationClass II
Reason for RecallDefective container: products are packaged in pouches which may not have been fully sealed
Product Quantity4,422,000 pouches
Recall NumberD-845-2013
Product DescriptionParsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm
Code InfoLot # 10121996, Exp 7/13
ClassificationClass II
Reason for RecallDefective container: products are packaged in pouches which may not have been fully sealed
Product Quantity472,000 pouches
Recall NumberD-846-2013

Class II Devices Event

Event ID65444
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternNationwide Distribution including Texas, Ohio, and Missouri.
 

Associated Products

Product DescriptionInvue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
Code InfoLot/Serial Numbers: 027104, 027105
ClassificationClass II
Reason for RecallDevice design.
Product Quantity12 devices
Recall NumberZ-1927-2013

Class II Devices Event

Event ID65470
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomerieux Inc
CityHazelwood
StateMO
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
 

Associated Products

Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1907-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1908-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1909-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE. Part number: 414539. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1910-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1911-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1912-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1913-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1914-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1915-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1916-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1917-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV. Part number: 414567. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1918-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1919-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1920-2013
Product DescriptionbioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Code Infoversion 6.01
ClassificationClass II
Reason for RecallA product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
Product Quantity12,384 total kits
Recall NumberZ-1921-2013

Class II Devices Event

Event ID65486
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Instruments Div. of Stryker Corporation
CityPortage
StateMI
CountryUS
Distribution PatternWorldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN.
 

Associated Products

Product DescriptionSonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
Code Info5450-850-000 (Console 110V with Pedal & Pole) S/N 1131300134, 1131900074, 1200500134, 1203200244, 1210100114, 1131300144, 1131900084, 1200500144, 1203200254, 1210100124, 1131300154, 1131900094, 1200500154, 1203200274, 1210100134, 1131300164, 1131900104, 1200500164, 1203700954, 1210100144, 1131300174, 1131900114, 1200500174, 1203700964, 1210100154, 1131300184, 1131900124, 1200500184, 1203700974, 1210700014, 1131300194, 1132800114, 1200500194, 1203900024, 1210700024, 1131300204, 1132800124, 1200500204, 1204000044, 1210700034, 1131300214, 1132800134, 1201300494, 1204000054, 1210700044, 1131300224, 1132800144, 1201300544, 1207400154, 1210700054, 1131300234, 1132800154, 1201300754, 1207400164, 1213800114, 1131300244, 1132800164, 1201300764, 1207400174, 1213800124, 1131900014, 1132800174, 1201300774, 1207400184, 1213800134, 1131900024, 1132800184, 1201300784, 1208300014, 1213800144, 1131900034, 1132800194, 1201300794, 1208300024, 1213800154, 1131900044, 1132800204, 1203200214, 1208300034, 1131900054, 1200500114, 1203200224, 1208300044, 1131900064, 1200500124, 1203200234, 1208300054.
ClassificationClass II
Reason for RecallA supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012.
Product Quantity215 units total
Recall NumberZ-1878-2013
Product DescriptionSonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
Code Info5450-851-000(Console 100V) S/N 1127900134, 1133400114, 1202400224, 1205800094, 1226800284, 1127900144, 1133400124, 1202400234, 1205800104, 1226800294, 1127900154, 1133400134, 1202400244, 1206200574, 1226800304, 1127900164, 1133400144, 1203700594, 1206200584, 1228500194, 1127900174, 1133400154, 1203700604, 1206200594, 1228500204, 1127900184, 1133900014, 1205100514, 1222800034, 1228500214, 1127900194, 1133900024, 1205100524, 1222800044, 01J0018, 1127900204, 1133900034, 1205100534, 1224800314, 02B0052, 1130500054, 1133900044, 1205100544, 1225500084, 02G0091, 1130500064, 1133900054, 1205100554, 1225500094, 05H0386, 1130500074, 1201300384, 1205100564, 1225500104, 1130500084, 1202400154, 1205100574, 1225500114, 1130800374, 1202400164, 1205100584, 1225500124, 1130800384, 1202400174, 1205100594, 1226800234, 1130800394, 1202400184, 1205100604, 1226800244, 1130800404, 1202400194, 1205800064, 1226800254, 1130800414, 1202400204, 1205800074, 1226800264, 1130800424, 1202400214, 1205800084, 1226800274.
ClassificationClass II
Reason for RecallA supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012.
Product Quantity215 units total
Recall NumberZ-1879-2013
Product DescriptionSonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
Code Info5450-852-000 (Console 230V) with SN: 1134000114, 1206800484 1210900274, 1134000124, 1206800494, 1210900284,1134000134 1206800504, 1210900294, 1134000144, 1206800514, 1210900304, 1134000154, 1206800524, 1211800064, 1134000164, 1206800534, 1211800074, 1134000174, 1206800544, 1211800084, 1134000184, 1208700014, 1211800094, 1134000194, 1208700024, 1212900014, 1134000204, 1208700034, 1213100114, 1201700324, 1208700044, 1213100124, 1201700334, 1208700054, 1213100134, 1201700344, 1209400164, 1213100144, 1201700354, 1209400174, 1213100154, 1201700364, 1209400184,1206500014, 1209400194, 1206500024, 1209400204, 1206500034, and 1210900264.
ClassificationClass II
Reason for RecallA supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012.
Product Quantity215 units total
Recall NumberZ-1880-2013

Class II Drugs Event

Event ID65495
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Health Packaging
CityColumbus
StateOH
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionZolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
Code InfoLot #: 114215, Exp 7/13; 114216, Exp 7/13; 114217, Exp 7/13; 120087, Exp 9/13; 120295, Exp 9/13; 121573, Exp 6/14; 123572, Exp 9/14; 123983, Exp 9/14; 130071, Exp 2/15
ClassificationClass II
Reason for RecallUnit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
Product Quantity48.230 carton units
Recall NumberD-856-2013

Class II Drugs Event

Event ID65515
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMethylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
Code Info34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.
ClassificationClass II
Reason for RecallFailed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Product Quantity16,293 bottles
Recall NumberD-847-2013
Product DescriptionMethylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
Code Info34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.
ClassificationClass II
Reason for RecallFailed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Product Quantity13,478 bottles
Recall NumberD-848-2013
Product DescriptionMethylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
Code Info34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.
ClassificationClass II
Reason for RecallFailed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Product Quantity7,579 bottles
Recall NumberD-849-2013

Class II Drugs Event

Event ID65543
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAstraZeneca Pharmaceuticals LP
CityWilmington
StateDE
CountryUS
Distribution PatternUSA and Puerto Rico
 

Associated Products

Product DescriptionMERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30
Code InfoNDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
ClassificationClass II
Reason for RecallPresence of Precipitate; potential for incomplete constitution upon addition of diluent.
Product Quantity81,900 total vials
Recall NumberD-840-2013

Class II Drugs Event

Event ID65582
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest-Ward Pharmaceutical Corp.
CityEatontown
StateNJ
CountryUS
Distribution PatternGA
 

Associated Products

Product DescriptionVersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
Code InfoLot 69968B 03/14
ClassificationClass II
Reason for RecallDiscoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Product Quantity118 bottles
Recall NumberD-839-2013

Class II Devices Event

Event ID65605
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternUS Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.
 

Associated Products

Product DescriptionMobiletta Mira Mobile X-ray System
Code InfoModel number 10273100
ClassificationClass II
Reason for RecallSiemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This imposes a potential risk of squeezing the toes of the user or another person.
Product Quantity39
Recall NumberZ-1875-2013

Class II Devices Event

Event ID65653
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA, including the states of CT, VA, FL, TX, CO and MS. and the country of Jamaica.
 

Associated Products

Product DescriptionIndus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place.
Code InfoLot Numbers: 7140.014; 6486.008 Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R
ClassificationClass II
Reason for RecallDifficulty removing screws from the Invue caddies.
Product Quantity8
Recall NumberZ-1933-2013

Class II Drugs Event

Event ID65701
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSanofi US
CityBridgewater
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionRifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
Code InfoLot # 3097657, Exp 3/15
ClassificationClass II
Reason for RecallSubpotent drug: low fill volume in some of the capsules
Product Quantity2,462 bottles
Recall NumberD-841-2013

Class II Devices Event

Event ID65706
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternUSA Nationwide Distribution including the states of: TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.
 

Associated Products

Product DescriptionDimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
Code InfoTACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiation date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14.
ClassificationClass II
Reason for RecallSiemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
Product Quantity5423
Recall NumberZ-1924-2013

Class II Devices Event

Event ID65724
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPrecision Dynamics Corporation
CityValencia
StateCA
CountryUS
Distribution PatternUS Distribution including the states of SC, TX, TN, WA, OK.
 

Associated Products

Product DescriptionNon-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.
Code InfoPart Number: PDC PN STERVIS (Viscot PN 1437-100) Lot: 061313.
ClassificationClass II
Reason for RecallPDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.
Product Quantity1,200 pens
Recall NumberZ-1872-2013

Class II Food Event

Event ID65730
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAqua Star (USA) Corp.
CitySeattle
StateWA
CountryUS
Distribution PatternProducts were directly distributed to NJ and MA and further distributed to PA, NJ, and NY.
 

Associated Products

Product DescriptionThe master case Bar Code is 20731149654062 and the Retail UPC is 7 31149 65406 8. The Retail Label reads in part "*** Aqua Star Raw Shrimp Easy-Peel Shell-On*** Ready to Cook *** Net Wt 1 lb (454g) ***"
Code InfoDate Code SGE-12/282 and Retail UPC 7 31149 65406 8.
ClassificationClass II
Reason for RecallAqua Star Raw Frozen Shrimp Easy-Peel Shell-On, Ready to Cook, 1 lb. plastic bags, date code SGE-12/282 was recalled due to Salmonella.
Product Quantity131 cases/20 packages/1 lbs.
Recall NumberF-1786-2013

Class II Devices Event

Event ID65757
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
CitySaint Paul
StateMN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE.
 

Associated Products

Product DescriptionMedtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Code InfoLot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.
ClassificationClass II
Reason for RecallMedtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not fit into a 7F sheath, making any mis-labeled introducer components unusable in a clinical case.
Product Quantity269
Recall NumberZ-1876-2013

Class II Food Event

Event ID65771
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOlam Tomato Processors, Inc.
CityLemoore
StateCA
CountryUS
Distribution PatternProduct sold at Dollar Tree and Deals, Dollar Express and Dollar Bills stores nationwide.
 

Associated Products

Product DescriptionMild Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759137; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA
Code InfoThe production codes for the Mild Chunky Salsa (UPC 3927759137) are L12142 (Best By Date June 2015) and L04093 (Best By Date October 2015)
ClassificationClass II
Reason for RecallThe firm received complaints of large fragments of glass that were found inside the Mild and Medium Chunky Salsa.
Product Quantity29,801 cases
Recall NumberF-1788-2013
Product DescriptionMedium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA
Code InfoFor the Medium Chunky Salsa (UPC 3927759139) is L01313 (Best By Date July 2015)
ClassificationClass II
Reason for RecallThe firm received complaints of large fragments of glass that were found inside the Mild and Medium Chunky Salsa.
Product Quantity12,870 cases
Recall NumberF-1789-2013

Class II Devices Event

Event ID65781
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNestle HealthCare Nutrition
CityMinnetonka
StateMN
CountryUS
Distribution PatternUS Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.
 

Associated Products

Product DescriptionNestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.
Code InfoREF 08310400 - Compat® Nasogastric Feeding Tube 8 French (8Fr) in the following lots: 01413G 02412K 08211Z 08712W 14212U 14611P 21512Y 35411H REF 08310500- Compat® Nasogastric Feeding Tube 12 French (12Fr) in the following lots: 01211AV 01513N 04111D, 04111P, 04111V 05812F 05912F 06313N 21512G 23412BV 34712V 35411U REF 08310600 - Compat® Nasogastric Feeding Tube 10 French (10Fr) in the following lots: 08111M 08712D 10211E 13712W 21512F 05312N
ClassificationClass II
Reason for RecallNestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
Product Quantity37,310
Recall NumberZ-1922-2013

Class II Devices Event

Event ID65786
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
CityHIROSHIMA
State
CountryJP
Distribution PatternWorldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
 

Associated Products

Product DescriptionMHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated
Code InfoSerial Numbers #s 201902 and 203901
ClassificationClass II
Reason for RecallSoftware anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.
Product Quantity14 (2 in US)
Recall NumberZ-1931-2013

Class II Food Event

Event ID65801
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGiant Eagle
CityPittsburgh
StatePA
CountryUS
Distribution PatternGiant Eagle retail stores in 4 states.
 

Associated Products

Product DescriptionGiant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 This product was packaged in a facility that also processes peanuts, nuts, milk products, soy, wheat, sesame seeds, whey and eggs. Distributed By: Giant Eagle, Inc. Pittsburgh, PA 15328-2809
Code InfoAll codes
ClassificationClass II
Reason for RecallThe firm has issued a recall on Giant Eagle Candy Place Chocolate Covered Peanuts with UPC 3003404313. The product has whey in the ingredients and the label does not clearly state that there is a milk allergen. (only whey is listed in the ingredient statement).
Product QuantityUnknown
Recall NumberF-1790-2013

Class II Drugs Event

Event ID65807
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest-Ward Pharmaceutical Corp.
CityEatontown
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
Code InfoLot #: a) 68679A, 68679C, Exp 01/15; 64456A, Exp 04/15; 68980A, Exp 05/15; 69234A, 69235A, Exp 07/15; 69607A, Exp 11/15; 69609C, 69835A, Exp 01/16; b) 64455B, Exp 08/13; 64456C, Exp 04/14; 64457A, Exp 10/14, 68679B, 68680A, Exp 01/15; 68980B, Exp 05/15; 69607B, 69608A, Exp 11/15; 69609B, Exp 01/16; c) 64455A, 64455C, 64455D, Exp 08/13; 64456B, Exp 04/14; 64457B, Exp 10/14; 68680B, Exp 01/15; 68980C, 68981A, Exp 05/15; 69608B, Exp 11/15; 69609A, Exp 01/16; 70169A, Exp 05/16
ClassificationClass II
Reason for RecallFailed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
Product Quantity51,704 bottles
Recall NumberD-853-2013

Class II Devices Event

Event ID65819
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmASO, LLC
CitySarasota
StateFL
CountryUS
Distribution PatternNationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
 

Associated Products

Product DescriptionCVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot #s: 101173, 102040, 1020631, 111450, 112092, 112102, 112623, 114833, 114843, 114853, 114863, 114873, 114883, 114843, 114853, 114863, 114873, 114883, 120343, 123542, 124890, 126582, 130313, 130973, 136592, 141962, 145172, 149421, 149742, 149752, 149762, 149772, 149992, 154192, 158761, 165422, 169961, 170232, 172572, 177182, 180302, 183821, 193150, 193542, 198062, 204742,207610, 228372, 231481, 233652, 234272, 238871, 245421, 259031, 265030, 310081, 312060, 318012, 318311, 324352, 324631, 335661, 345082, 363801.833711, 384420, 407470, 437940, 471090, 511940, 525910, 545400, 552850, 28781, 28982, 29040, and 29041
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1888-2013
Product DescriptionDiscount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot #: 208351
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1889-2013
Product DescriptionDuane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot #s: 175770 and 209340
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1890-2013
Product DescriptionHEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot #s: 143560, 171871, 250861, 379061, 402860, 418910, 513820, and 544130
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1891-2013
Product DescriptionLeader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1892-2013
Product DescriptionMeijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot #s: 123120 and 324880
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1893-2013
Product DescriptionPremier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot#s: 218620, 354840, 546660, 115451, 223771, 285451, 324201, 366061, 193702, 227822, 263592, 302572, 123313, 123293, 123303 123313, 123283, and 28955
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1894-2013
Product DescriptionTopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot#s: 121860, 141870, 145000, and 147910
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1895-2013
Product DescriptionWalgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds.
Code InfoASO Packaging Lot#s: 100253, 103163, 105082, 109110, 111711, 114813, 120250, 123273, 126652, 130303, 142072, 144902, 144912, 144932, 144942, 144952, 144962, 144982, 144992, 145002, 145012, 145022, 145032, 145042, 145052, 145062, 145412, 1453470, 154452, 158512, 163272, 168391, 184482, 190112, 191830, 204872, 214272, 223482, 225511, 225820, 234871, 235941, 237882, 238041, 242061, 248891, 264180, 267631, 270552, 271031, 280441, 283001, 290581, 291202, 297932, 306912, 312671, 316222, 320221, 322632, 324362, 324901, 329651, 334670, 338241, 368051, 390340, 473410, 481090, 517690, 532540, 549000, 558990, 28538, and 29020
ClassificationClass II
Reason for RecallThis recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Product QuantityTotal 2,689,560 pouches (2 cards/pouch)
Recall NumberZ-1896-2013

Class II Drugs Event

Event ID65826
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionTerazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
Code InfoLot # N07321, Exp 6/14
ClassificationClass II
Reason for RecallLabeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
Product Quantity6267 bottles
Recall NumberD-842-2013

Class II Devices Event

Event ID65843
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRadiometer America Inc
CityWestlake
StateOH
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada.
 

Associated Products

Product DescriptionTCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brønshøj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
Code InfoTCM4 series Base Units: 000-154, 391-876, 391-878 and 391-880 below R0175N009 & Power Supply (Spare part): 910-246. Serial #: 154R0002N002, 154R0004N003, 154R0004N008, 154R0005N004, 154R0005N005, 154R0005N005-U, 154R0005N006-154R0005N006, 154R0006N005, 154R0006N006, 154R0006N008-154R0006N010, 154R0007N001-154R0007N010, 154R0008N001, 154R0008N002, 154R0008N002U, 154R0008N003, 154R0008N005-154R0008N010, 154R0009N004, 154R0009N010, 154R0011N003, 154R0011N006-154R0011N009, 154R0012N001-154R0012N003, 154R0013N004, 154R0013N005, 154R0013N007-154R0013N010, 154R0014N009, 154R0016N001-154R0016N003, 154R0016N008, 154R0016N009, 154R0016N010, 154R0017N007, 154R0019N001-154R0019N005, 154R0019N007, 154R0019N009, 154R0019N010, 154R0020N002, 154R0021N003, 154R0021N004U, 154R0021N005, 154R0021N008, 154R0021N010, 154R0022N008-154R0022N010, 154R0023N006, 154R0023N007, 154R0023N009, 154R0023N010, 154R0024N004-154R0024N006, 154R0024N009, 154R0024N010, 154R0025N002, 154R0025N004-154R0025N006, 154R0026N008, 154R0027N001-154R0027N005, 154R0027N007, 154R0028N001-154R0028N004, 154R0028N006-154R0028N006, 154R0029N003-154R0029N007, 154R0029N009, 154R0030N001, 154R0030N004-, 54R0030N007, 154R0030N008U, 154R0031N001, 154R0031N003-154R0031N009, 154R0034N006, 154R0034N008, 154R0034N009, 154R0035N002, 154R0035N003, 154R0035N006, 154R0035N008, 154R0035N009, 154R0035N010, 154R0036N010, 154R0036N002-154R0036N009, 154R0038N002-154R0038N006, 154R0040N001, 154R0040N002, 154R0040N009, 154R0040N010, 154R0041N001, 154R0041N003, 154R0041N004, 154R0041N006-154R0041N008, 154R0042N001, 154R0042N002, 154R0042N004, 154R0042N005, 154R0046N002, 154R0046N004, 154R0046N006-154R0046N008, 154R0047N002, 154R0048N002-154R0048N004, 154R0048N007, 154R0050N001-154R0050N009, 154R0051N001, 154R0051N003-154R0051N003, 154R0052N001-154R0052N009, 154R0053N007-154R0053N010, 154R0054N001, 154R0054N002, 154R0054N004, 154R0055N002-154R0055N006, 154R0056N001, 154R0056N002, 154R0056N005, 154R0056N006, 154R0056N008-154R0056N010, 154R0057N001-154R0057N004, 154R0057N008, 154R0057N009, 154R0058N001-154R0058N003, 154R0059N002-154R0059N004, 154R0059N006-154R0059N008 154R005N001, 154R0060N007-154R0060N009, 154R006N003, 154R0071N014, 154R031N010, 154R039N005, 154R039N006, 28N012, 28N013, 32N002, 381-880R0008N005 391-876R0001N003, 391-876R0001N006, 391-876R0001N007, 391-876R0001N010, 391-876R0002N004, 391-876R0002N009, 391-876R0003N001, 391-876R0003N004-391-876R0003N006, 391-876R0003N008, 391-876R0003N009, 391-876R0004N002, 391-876R0004N002U, 391-876R0004N009, 391-876R0004N014, 391-876R0005N003, 391-876R0005N004, 391-876R0006N011, 391-876R0007N007, 391-876R0007N008, 391-876R0007N010, 391-876R0011N001, 391-876R0011N002, 391-876R0011N009, 391-876R0011N010, 391-876R0012N002, 391-876R0012N002U, 391-876R0012N007, 391-876R0012N008, 391-876R0012N010, 391-876R0014N002, 391-876R0014N003, 391-876R0014N005, 391-876R0014N006, 391-876R0016N007, 391-876R0016N010, 391-876R0016N010U, 391-876R0017N002, 391-876R0018N004-391-876R0018N009, 391-876R0019N001, 391-876R0019N008-391-876R0019N010, 391-876R0020N001, 391-876R0022N002-391-876R0022N008, 391-876R0022N009-U, 391-876R0023N001, 391-876R0023N006, 391-876R0023N009, 391-876R0024N001-391-876R0024N003, 391-876R0024N005, 391-876R0024N006, 391-876R0026N001, 391-876R0026N002, 391-876R0026N005, 391-876R0026N006, 391-876R0027N007, 391-876R0027N008, 391-876R0028N002, 391-876R0028N018-391-876R0028N020, 391-876R0029N005, 391-876R0029N007, 391-876R0029N009, 391-876R0029N012, 391-876R0029N019, 391-876R0030N001, 391-876R0030N002, 391-876R0030N006-391-876R0030N008, 391-876R0031N009, 391-876R0031N011, 391-876R0031N012, 391-876R0031N013, 391-876R0031N016, 391-876R0031N020, 391-876R0032N020, 391-876R0032N018, 391-876R0033N003, 391-876R0033N005, 391-876R0034N004, 391-876R0034N004U, 391-876R0034N006, 391-876R0034N007, 391-876R0034N009, 391-876R0034N010, 391-876R0034N017, 391-876R0034N018, 391-876R0035N005, 391-876R0035N006, 391-876R0035N007U, 391-876R0035N008, 391-876R0035N017, 391-876R0036N001, 391-876R0036N003, 391-876R0036N004, 391-876R0036N007, 391-876R0036N008, 391-876R0036N010, 391-876R0036N011, 391-876R0036N013, 391-876R0036N016, 391-876R0037N010, 391-876R0037N012, 391-876R0037N013, 391-876R0038N003, 391-876R0038N017, 391-876R0039N003, 391-876R0039N004, 391-876R0039N006, 391-876R0039N008, 391-876R0039N009, 391-876R0039N011, 391-876R0039N012, 391-876R0040N001, 391-876R0040N001U, 391-876R0040N015, 391-876R0040N018, 391-876R0040N019, 391-876R0041N003, 391-876R0041N004, 391-876R0041N005, 391-876R0041N011U, 391-876R0041N012-391-876R0041N016, 391-876R0042N001, 391-876R0042N005-391-876R0042N012, 391-876R0042N015, 391-876R0042N020, 391-876R0043N001, 391-876R0043N002, 391-876R0043N004-391-876R0043N009, 391-876R0043N014, 391-878R0002N001, 391-878R0002N002, 391-878R0002N004-391-878R0002N006, 391-878R0004N008, 391-878R0004N009, 391-878R0004N013-391-878R0004N015, 391-878R0004N018-391-878R0004N020, 391-878R0005N001, 391-878R0005N002, 391-878R0005N011-391-878R0005N013, 391-878R0005N015, 391-878R0005N020, 391-878R0006N003, 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880R0151N016-880R0151N020, 880R0153N008, 880R0153N009, 880R0153N015-880R0153N017, 880R0154N014-880R0154N020, 880R0155N001-880R0155N003, 880R0155N012-880R0155N019, 880R0156N002, 880R0156N003, 880R0156N006, 880R0156N008, 880R0156N009, 880R0156N010, 880R0156N013, 880R0156N015, 880R0156N017, 880R0156N019, 880R0157N007, 880R0157N009, 880R0158N006, 880R0158N007, 880R0158N010, 880R0158N011, 880R0158N012, 880R0158N013, 880R0158N017, 880R0159N001, 880R0159N002, 880R0159N003, 880R0159N009, 880R0159N010-880R0159N019, 880R0161N014-880R0161N020, 880R0162N001-880R0162N005, 880R0165N008, 880R0165N009, 880R0165N010, 880R0167N003-880R0167N010, 880R0167N015, 880R0167N019, 880R0170N008, 880R0170N009, 880R0170N011, 880R0171N019, 880R0171N020, 880R0172N001, 880R0172N002, 880R0172N005, 880R0177N009, 880R0177N010, 880R0177N012, 880R0177N013, 880R0177N014, 880R0178N013, 880R0178N014, 880R0178N015, 880R0178N017-880R0178N020, 880R9999N999, 888R0178N016, R0011N002, R0014N012, R0016N008, R0027B009, R0027N009, R0030N007, R0041N001, R0048N005, R035N001 & TCMXX 00000154R00.
ClassificationClass II
Reason for RecallRADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
Product Quantity5,874 units
Recall NumberZ-1930-2013

Class II Drugs Event

Event ID65882
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmApotex Inc
CityRichmond Hill
State
CountryCA
Distribution PatternNationwide
 

Associated Products

Product DescriptionLatanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
Code InfoLot #: JX1877, Exp 06/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
Product Quantity50,982 bottles
Recall NumberD-852-2013

Class III Biologics Event

Event ID39944
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLF32774
ClassificationClass III
Reason for RecallBlood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
Product Quantity1 unit
Recall NumberB-1964-13

Class III Biologics Event

Event ID44002
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityToledo
StateOH
CountryUS
Distribution PatternProducts were distributed to a hospital in Akron, OH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info042FP20630
ClassificationClass III
Reason for RecallBlood product, with donor hematocrit determined using an analyzer for which the normal control was out of range, was distributed.
Product Quantity1 component
Recall NumberB-1935-13

Class III Biologics Event

Event ID48723
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jun-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBioLife Plasma Services L.P.
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info52947810 ,52952302 ,52985348 ,52992261 ,52996900 , 53000354 ,53353603 ,53665614 ,53890016 ,54143128 , 57567679 ,57569635 ,61844841 ,61849853 ,62426619 , 62534192 ,62538435 ,62540117 ,62940078 ,62980616 , 63409383 ,63673265 ,63683431 ,63687392 ,63955064 , 63960624 ,63960846 ,63961997 ,63968668 ,64360294 , 64428642 ,64428680 ,64432625 ,64432649 ,64435985 , 64436012 ,64438764 ,64438771 ,64830100 ,65039977 , 65041956 ,65045268 ,65059777 ,65062838 ,65065402 , 65346020 ,65601594 ,65631010 ,65765173 ,65979266 , 65992234 ,66101284 ,66118299 ,66123613 ,66129721 , ,66212874 ,66215868 ,66222347 ,66225560 ,66231820 , 66397120 ,66401872 ,66404101 ,66413806 ,66769415 , 66843870 ,67078288 ,67078325 ,67101436 ,67536085 , 67551064 ,67597604 ,67602841 ,67615582 ,67623945 , 67630851 ,67639137 ,67703975 ,67709090 ,67718320 , 67754816 ,67755486 ,67763788 ,67767731 ,67774197 , 67779598 ,67793334 ,67795321 ,67838967 ,67843060 , 67848621 ,67852291 ,67881901 ,68095321 ,68099824 , 68101244 ,68166915 ,68173043 ,68795290 ,68798208 , 68808037 ,68863401 ,68869908 ,69194924 ,69198038 , 69203411 ,69206870 ,69211508 ,69244131 ,69246098 , 69555954 ,69563355 ,69895364 ,69898624 ,69904578 , 69909580 ,69918889 ,69922930 ,69925238 ,69930768 , 69944673 ,70486230 ,71187525 ,71189567 ,71193267 , 71195988 ,71198330 ,71199047 ,71199054 ,71202969 , 71204673 ,71205328 ,71254173 ,71257075 ,71467153 , 71581026 ,71584263 ,71805702 ,72244838 ,72245842 , 72380796 ,72381748 ,72383452 ,72484333 ,72601082 , 72609309 ,72604120 ,72626177 ,72629222 ,72707777 , 72807668 ,72869338 ,72901656 ,73070283 ,73244875 , 73246701 ,73248002 ,73443797 ,73457107 ,73477617 , 73558620 ,73806417 ,73807384 ,73809159 ,73810148 , 73853152 ,73855743 ,73857747 ,73859420 ,73889731 , 74014156 ,74016952 ,74462100 ,74465552 ,74537709 , 74539390 ,74670260 ,74706921 ,74885701 ,74886586 , 74932528 ,74932696 ,74973750 ,74974870 ,75120863 , 75122966 ,75177539 ,75243739 ,75437572 ,75438142 , 75440008 ,75442729 ,75444570 ,75521318 ,75522667 , 75524661 ,75525958 ,75527778 ,75528683 ,75528898 , 75529871 ,75557768 ,75558635 ,75566104 ,75570118 , 75580605 ,75582074 ,75654955 ,75655174 ,75740306 , 75745431 ,75746407 ,75747442 ,75778347 ,75782832 , 75786083 ,76027611 ,76041983 ,76044472 ,76047121 , 76060083 ,76102875 ,76161230 ,76165955 ,76182198 , 76184291 ,76185236 ,76187421 ,76189982 ,76190377 , 76233265 ,76237478 ,76292804 ,76393440 ,76399138 , 77085887 ,77142061 ,77144935 ,77541666 ,77543233 , 77545268 ,77546913 ,77562227 ,77563194 ,77564849 , 77621047 ,77622020 ,77623409 ,78773547 ,78823303 , 79221580 ,79223997 ,79275323 ,79479868 ,79483353, 79538763 ,79830546 ,79833318 ,79838894 ,79842457 , 80155942 ,80166993 ,80168010 ,80172901 ,80177760 , 80508731 ,80521723 ,80525905 ,80534860 ,80593706 , 80595014 ,80604068 ,80608042 ,80608721 ,80608738 , 80882732 ,80899549 ,80904304
ClassificationClass III
Reason for RecallBlood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed.
Product Quantity287
Recall NumberB-2066-13

Class III Biologics Event

Event ID57147
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Aug-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-Counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCA , Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW14281041940100E, W14281041940200C, W142810419404008, W142810419405006, W142810419406004, W142810419407002, W14281041940900Z, W14281041941000C, W14281041941100A, W142810419412008, W142810419413006, W142810419416000, W14281041941700Z, W14281041941800X, W14281041941900V, W142810419420008, W142810419421006, W142810419422004, W142810419423002, W14281041942500Z, W14281041942600X, W14281041942700V, W14281041942800T, W142810419430004, W142810419431002, W142810419432000, W14281041943300Z, W14281041943400X, W14281041943500V, W14281041943600T, W14281041943700R, W14281041943800P.
ClassificationClass III
Reason for RecallBlood products, which labels were applied to products with incorrect or missing information, were distributed.
Product Quantity32 units
Recall NumberB-1891-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW142810419408000, W142810419415002, W14281041942900R.
ClassificationClass III
Reason for RecallBlood products, which labels were applied to products with incorrect or missing information, were distributed.
Product Quantity3 units
Recall NumberB-1892-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info W142810419414004, W14281041940300A
ClassificationClass III
Reason for RecallBlood products, which labels were applied to products with incorrect or missing information, were distributed.
Product Quantity2 units
Recall NumberB-1893-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW14281041942900R, W142810419408000, W142810419415002.
ClassificationClass III
Reason for RecallBlood products, which labels were applied to products with incorrect or missing information, were distributed.
Product Quantity3 units
Recall NumberB-1894-13

Class III Biologics Event

Event ID65453
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifepoint, Inc.
CityCharleston
StateSC
CountryUS
Distribution PatternSouth Carolina
 

Associated Products

Product DescriptionCornea
Code Info20130190L1; 20130190R1
ClassificationClass III
Reason for RecallCorneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 corneas
Recall NumberB-2041-13

Class III Food Event

Event ID65723
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmGolden Beach Inc
CityTorrance
StateCA
CountryUS
Distribution PatternKY, VA, MS, MO, FL, OH, IN, AL, CA,SC,OK
 

Associated Products

Product DescriptionSunny Sea Sardines in Tomato Sauce, 24 cans/case, 15 oz.
Code InfoLot # 10471 November 1, 2015 3700/01173
ClassificationClass III
Reason for RecallGolden Beach Inc. is recalling Sunny Sea Sardines in Tomato Sauce for decomposition.
Product Quantity880 cases
Recall NumberF-1787-2013

Class III Drugs Event

Event ID65856
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGlaxoSmithKline, LLC.
CityZebulon
StateNC
CountryUS
Distribution PatternU.S. Nationwide
 

Associated Products

Product DescriptionTUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02
Code InfoLot 3C11 and 3C11A
ClassificationClass III
Reason for RecallPresence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Product Quantity300,480 bottles
Recall NumberD-850-2013

Class III Drugs Event

Event ID65877
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSandoz Incorporated
CityBroomfield
StateCO
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionIntrovale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
Code InfoLots: LF01643C, LF01644C, Exp 7/14
ClassificationClass III
Reason for RecallContraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Product Quantity8, 681 unit cartons
Recall NumberD-854-2013

Class III Drugs Event

Event ID65881
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmActavis Inc
CityParsippany
StateNJ
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionBuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Code InfoLot #: CG2D18A, Exp 06/14
ClassificationClass III
Reason for RecallFailed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Product Quantity15,132 bottles
Recall NumberD-855-2013

Mixed Classification Biologics Event

Event ID38801
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityCleveland
StateOH
CountryUS
Distribution PatternOH, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info42X20495
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1961-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info42X20495
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1962-13
Product DescriptionRecovered Plasma
Code Info42X20495
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1963-13

Mixed Classification Biologics Event

Event ID38808
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityCleveland
StateOH
CountryUS
Distribution PatternOH, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info42FX51417, 42M22729
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2027-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info42FX51417, 42M22729
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2028-13
Product DescriptionRecovered Plasma
Code Info42FX51417, 42M22729
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2029-13

Mixed Classification Biologics Event

Event ID44226
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityColumbus
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info16GM57521
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1911-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info16GM57521
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1912-13
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