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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Class I Drugs Event

Event ID61233
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Nov-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPhysicians Total Care, Inc
CityTulsa
StateOK
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionMorphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
Code InfoPTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00
ClassificationClass I
Reason for RecallLabeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Product Quantity540 tablets (9 containers of 60 tablets each)
Recall NumberD-1385-2012
Product DescriptionMorphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00
Code InfoPTC Drug Number: 4973. PTC Batch Number: 65J2. Batch Date: 10/13/2010. Expiration Date: 06/30/2012. NDC: 54868-4973-00
ClassificationClass I
Reason for RecallLabeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Product Quantity600 tablets (5 containers of 120 tablets each)
Recall NumberD-1386-2012

Class I Food Event

Event ID61497
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Mar-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmClub Chef LLC
CityCovington
StateKY
CountryUS
Distribution PatternProduct was shipped to the following states: IL, IN, KY, OH, TN & VA.
 

Associated Products

Product DescriptionSalsa in 12 oz., 16 oz., and 5 lb. plastic containers. The product labels reads as follows: PREMIUM QUALITY Private Selection Natural***SALSA NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 45202***1-800-697-2448***" and PREMIUM QUALITY Private Selection Natural PICO DE GALLO NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 45202***1-800-697-2448*** and heinens" Fresh***Salsa All Natural Net. Wt. 16oz. (1lb) 454g***Ingredients: Tomatoes***Jalapeno***PACKED FOR HEINENS BY CLUB CHEF, LLC and heinens" Fresh Bruschetta All Natural Net. Wt. 16oz. (1lb) 454g ***Ingredients: Tomatoes***Jalapeno***PACKED FOR HEINENS BY CLUB CHEF, LLC
Code InfoPrivate Selection Brand: PICO DE GALLO-UPC# 11111091135, HOT SALSA-UPC# 1111091139 & MILD SALSA-UPC# 1111091137; heinen's brand: HOT SALSA-UPC# 2060100024 & MILD SALSA-UPC# 2060100026. Both brands have Use By 3/27/12.
ClassificationClass I
Reason for RecallSouth Florida Produce of Boynton Beach in Florida shipped fresh jalapeno peppers to Castellini Company in Wilder Kentucky. Castellini shipped the peppers to a store in Ohio, where the Ohio Department of Agriculture collected a sample of these peppers which subsequently were found contaminated with Salmonella. This same lot of fresh peppers was shipped to Club Chef which manufactured the Salsa which is under recall and identified in this Recall Enterprise System document.
Product Quantity422 cases
Recall NumberF-1443-2012

Class I Devices Event

Event ID61639
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternNationwide Distribution-including the states of AL, FL, GA, MO, and VA.
 

Associated Products

Product DescriptionGE Healthcare, Aestiva/5 7900 SmartVent", anesthesia machine, GE Healthcare P.O. Box 7550 Madison, WI 53707-7550. This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional). This device is to be used only by trained and qualified medical professionals
Code InfoSerial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969
ClassificationClass I
Reason for RecallGE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This may cause prolonged or persistent hypotension requiring medical intervention. To date, no injury has been reported to GE Healthcare associated with this issue.
Product Quantity8
Recall NumberZ-1787-2012

Class I Devices Event

Event ID61843
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNidek Medical Products Inc
CityBirmingham
StateAL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of ALBANIA, ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ENGLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, KAZAKHSTAN, KINGDOM OF SAUDI ARABIA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPPINES, PORTUGAL, REPUBLIC OF CHINA, REPUBLIC OF SOUTH AFRICA, RUSSIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH AUSTRALIA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, THE NETHERLANDS, TOGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES, and VIETNAM.
 

Associated Products

Product DescriptionNIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity7889 units
Recall NumberZ-1774-2012
Product DescriptionNIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity
Recall NumberZ-1775-2012
Product DescriptionNIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity82 units
Recall NumberZ-1776-2012
Product DescriptionNIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity335 units
Recall NumberZ-1777-2012
Product DescriptionNIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity730 units
Recall NumberZ-1778-2012
Product DescriptionNIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity3638 units
Recall NumberZ-1779-2012
Product DescriptionNIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity14,585 units
Recall NumberZ-1780-2012
Product DescriptionNIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity1599 units
Recall NumberZ-1781-2012
Product DescriptionNIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
Code InfoSerial numbers 042-10000 through 102-07044
ClassificationClass I
Reason for RecallCapacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity18114 units
Recall NumberZ-1782-2012

Class I Food Event

Event ID61893
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSantos Inc.
CitySan Leandro
StateCA
CountryUS
Distribution PatternDistributed to retail markets in Northern California.
 

Associated Products

Product DescriptionSantos Brand, Bulgar Wheat, flour packed in clear plastic bags, 2 lbs.
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1461-2012
Product DescriptionSantos Brand, All Purpose flour packed in clear plastic bags, 2 lbs, 5lbs
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1462-2012
Product DescriptionSantos Brand, Cinnamon Sticks packed in clear plastic bags, 7oz, 14oz
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1463-2012
Product DescriptionSantos Brand, Cumin Seeds packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1464-2012
Product DescriptionSantos Brand, Fennel Seeds packed in clear plastic bags, 3.5 ounces, 7 ounces, 14 ounces, 2 pounds
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1465-2012
Product DescriptionSantos Brand, Deggi Mirch (Red Capsicum & Kashmiri Red Chile Powder) packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1466-2012
Product DescriptionSantos Brand, Garam Masala (Indian Spice Mix) packed in clear plastic bags, 7 ounces, 16 ounces
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1467-2012
Product DescriptionSantos Brand, Ginger Powder packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1468-2012
Product DescriptionSantos Brand, Cardamom packed in clear plastic bags, 3.5 ounces, 7 ounces
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1469-2012
Product DescriptionSantos Brand, Whole Mace packed in clear plastic bags, 3.5 ounces, 7 ounces
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1470-2012
Product DescriptionSantos Brand, Mustard Seeds packed in clear plastic bags, 3.5 ounces, 16 ounces
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1471-2012
Product DescriptionSantos Brand, Urid Split (Lentils) packed in clear plastic bags, 2 pounds, 4 pounds
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1472-2012
Product DescriptionSantos Brand, Suji (Farina) packed in clear plastic bags, 2 pounds
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1473-2012
Product DescriptionSantos Brand, garbanzo beans packed in clear plastic bags, 2 pounds, 4 pounds
Code InfoThere is no UPC code/lot code/expiration date on products.
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall NumberF-1474-2012

Class I Food Event

Event ID61896
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-May-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmGills Onions, LLC
CityOxnard
StateCA
CountryUS
Distribution PatternWorldwide to: Canada and nationwide to: retailers and foodservice distributors in California, Oregon, Washington, Arizona, Idaho, Texas, Illinois, Michigan, Arkansas, Ohio, Tennessee, New Jersey, Georgia, and Florida.
 

Associated Products

Product DescriptionDiced Red Onions, 7oz clear plastic clamshell labeled Gills Onions with the May 17, 2012 use by date, United States UPC 6 43550 00041 2. Fresh Diced Red Onions, Oignons rouges frais, en des, 198 grams, Canadian UPC 6 43550 00045 0.
Code Infolot code 51RDA1A2119
ClassificationClass I
Reason for RecallThe recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes.
Product Quantity2,360 lbs total
Recall NumberF-1539-2012
Product Description3/8" Diced Red Onions, 5 LB. Bag
Code Infolot code 51RDA1A2119
ClassificationClass I
Reason for RecallThe recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes.
Product Quantity2,360 lbs total
Recall NumberF-1540-2012
Product Description1/4" Diced Red Onions, 5 LB. Bag
Code Infolot code 51RDA1A2119
ClassificationClass I
Reason for RecallThe recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes.
Product Quantity2,360 lbs total
Recall NumberF-1541-2012

Class I Food Event

Event ID61970
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOskri Organics Corp.
CityLake Mills
StateWI
CountryUS
Distribution PatternAZ, CA, DE, FL, GA, MD, MI, MN, NJ, NY, NC, OR, TX, UT, VA, WA.
 

Associated Products

Product DescriptionOskri, Peach Granola, Gluten Free, Nut Free, Dairy Free, Vegan, Halal, Kosher, Ingredients: Buck Wheat , Peaches 20% Sunflower Seeds , Apricots, Date Syrup, Chicory Root extract, Rice protein., NET WT 3.5oz (100) G., UPC 66616111743, Oskri, Lake Mills, Wisconsin 53551.
Code InfoLot 75, P: 3/3/12, EXP: 9/9/13
ClassificationClass I
Reason for RecallOskri is recalling one lot of 3.53 oz bags of Peach Granola due to cashews being added to this product in error.
Product Quantity1056 bags
Recall NumberF-1543-2012

Class I Food Event

Event ID62290
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmIndonesian Food Mart
CityRockville
StateMD
CountryUS
Distribution PatternProduct was distributed nationwide and internationally to Australia, Canada, Slovenia, New Zealand, Brunei, Darussalam, Poland and Croatia.
 

Associated Products

Product DescriptionTempeh Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, Original, packaged in clear plastic packages in 30gm, 50gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com***
Code InfoProduct is not coded
ClassificationClass I
Reason for RecallImported food product tested positive for Salmonella.
Product Quantity123 orders were filled but quantities were not recorded on many invoices
Recall NumberF-1475-2012
Product DescriptionTempeh Super Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, packaged in clear plastic packages in 30 gm, 50 gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com***
Code InfoProduct is not coded
ClassificationClass I
Reason for RecallImported food product tested positive for Salmonella.
Product Quantity123 orders were filled but quantities were not recorded on many invoices
Recall NumberF-1476-2012

Class II Devices Event

Event ID57878
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-May-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmApp Pharmaceuticals Llc
CitySchaumburg
StateIL
CountryUS
Distribution PatternNationwide Distribution and Puerto Rico
 

Associated Products

Product DescriptionHEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Code InfoLot 406952 (Expiration Date 02/11)
ClassificationClass II
Reason for RecallCGMP Deviations: Incomplete documentation associated with test results.
Product Quantity133,150 vials
Recall NumberZ-1824-2012
Product DescriptionHEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Code InfoProduct Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
ClassificationClass II
Reason for RecallCGMP Deviations: Incomplete documentation associated with test results.
Product QuantityProduct Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Recall NumberZ-1825-2012

Class II Devices Event

Event ID61253
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Optisurgical Inc
CityLake Forest
StateCA
CountryUS
Distribution PatternNationwide distribution: MN only.
 

Associated Products

Product DescriptionTX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Code InfoProduct Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
ClassificationClass II
Reason for RecallTwo reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Product Quantity5units
Recall NumberZ-1817-2012

Class II Devices Event

Event ID61376
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Nov-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBiomet 3i, LLC
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternWorldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.
 

Associated Products

Product DescriptionImplant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.*** Product Usage: The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Code InfoLot #2010111529
ClassificationClass II
Reason for RecallOn November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
Product Quantity219 units in total
Recall NumberZ-1828-2012

Class II Food Event

Event ID61542
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPr Supplies Co., Inc.
CityBayamon
StatePR
CountryUS
Distribution PatternPuerto Rico only.
 

Associated Products

Product Description"***Queso Blanco del Pais***TRIDAS***Receta Original***"
Code Info16/3/2012
ClassificationClass II
Reason for RecallPR State Department sampling found positive results for Clostridium Clostridioforme
Product Quantity415 units
Recall NumberF-1457-2012
Product Description"***Queso del Pais***TRIDAS***Pasta y Queso "Guayaba"***"
Code Info16/3/2012
ClassificationClass II
Reason for RecallPR State Department sampling found positive results for Clostridium Clostridioforme
Product Quantity300 units
Recall NumberF-1458-2012
Product Description"***Queso del Pais***TRIDAS***Pasta y Queso "Mango"***"
Code Info16/3/2012
ClassificationClass II
Reason for RecallPR State Department sampling found positive results for Clostridium Clostridioforme
Product Quantity100 units
Recall NumberF-1459-2012

Class II Devices Event

Event ID61741
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMedtronic Navigation, Inc.
CityLittleton
StateMA
CountryUS
Distribution PatternNationwide Distribution including the states of CO, IN, and MN.
 

Associated Products

Product DescriptionMedtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Code InfoSerial Numbers: 125, 156, 234R.
ClassificationClass II
Reason for RecallSoftware Version 3.1.1 does not meet navigational accuracy.
Product Quantity3 units
Recall NumberZ-1849-2012

Class II Devices Event

Event ID61742
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam.
 

Associated Products

Product DescriptionSARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 12315 and Lot codes: 0552019, 0557299, 0562142, 0572238, 0575869, 0579315, 0584831, 0590890, 0594622, 0598430, 0604045, 0612256, 0625339, 0640189, 0646473, 0652905, 0656574, 0666574, 0671713, and 593606C.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1832-2012
Product DescriptionSARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 12325 and Lot codes: 0551680, 0553010, 0557571, 0559882, 0562967, 0566831, 0569995, 0575870, 0579316, 0584969, 0589928, 0593454, 0595251, 0601331, 0606816, 0611597, 0617494, 0622167, 0626795, 0629156, 0632515, 0636330, 0640190, 0643858, 0649159, 0652241, 0656575, 0663510, and 621463C.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1833-2012
Product DescriptionSARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 12325X and Lot codes: 558946, 0589263, 0603353, 0640527, and 0653443.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1834-2012
Product DescriptionSARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 13010 and Lot codes: 0590855, 0593791, 0597307, 0603718, 0616892, 0624831,0629341,0634937, 0636270, 0644444, 0646144, 0653230, 0666586, and 0669487.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1835-2012
Product DescriptionSARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 13020 and Lot codes: 0550552, 0555854, 0557327, 0559103, 0562503, 0566861, 0570455, 0574279, 0577885, 0581606, 0585963, 0590856, 0593457, 0597308, 0605179, 0609199, 0614248, 0618969, 0626379, 0628950, 0634171, 0636332, 0640518, 0646396, 0653231, and 0666719.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1836-2012
Product DescriptionSARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 13030 and Lot code: 0553041, 0555967, 0557330, 0559885, 0562990, 0564951, 0567668, 0570456, 0571580, 0575365, 0580822, 0583186, 0585529, 0590858, 0593455, 0596125, 0600250, 0605504, 0609198, 0614183, 0620033, 0623325, 0626858, 0634096, 0636271, 0638011, 0640980, 0650900, 0653232, and 628985C.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1837-2012
Product DescriptionSARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 144776 and Lot code: 0552165, 0560615, 0574341, 0586004, 0606472, 0614321, 0617360, 0622689, 0637775, 0640519, and 0653855.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1838-2012
Product Description24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 88813030 and Lot code: 0550551, 0568495, 0576844, 0586459, 0601958, 0626874, and 0635682.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1839-2012
Product DescriptionSPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 64625 and Lot code: NA17, NC07A, NG06, NG06A, and NL19.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1840-2012
Product DescriptionCUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 80001-01 and Lot code: MG21, MM04, NA24, ND21, NK01, NM31, and PA30.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1841-2012
Product DescriptionCPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code InfoCatalog number: 80004-02 and Lot code: MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23.
ClassificationClass II
Reason for RecallDuring production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity133,793 (each)
Recall NumberZ-1842-2012

Class II Devices Event

Event ID61761
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Feb-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAccumetrics Inc
CitySan Diego
StateCA
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionVerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Code InfoLot # WK0002A WK0003A WK0003B WK0004A WK0005A WK0006A WK0006B WK0006AR WK0006BR WK0007A WK0008A WK0009A WK0010A WK0010B WK0010C WK0011A WK0012A WK0013A WL0001A WL0001B WK0014A WK0015A WL0003A WL0004A WK0016A WL0005A WL0006A WL0007A WK0017A WK0018A WL0007B WL0008A WK0018B WK0018-5A WL0008-5A WL0009A WL0009-5A WK0019A WL0009B WL0010A WL0010-5A WL0010B WL0011-5A WL0011A WL0013A WL0012A WL0012-5A WL0015-5A WL0015A WL0016-5A WL0016A WL0017A WL0018A WL0018-5A WL0019A WL0020A WL0020-5A WL0018B WK0020A WL0021A WL0022A WL0023A WL0023-5A WL0024A WL0024B WL0025A WL0026A WL0026A WL026-5A WL0027 WL0028 WL0029 WL0029A WL0029B WL0030 WL0031 WL0030A WL0033 WL0034 WL0035 WL0036 WL0038 WL0033A WL0039 WL0040 WL0040A WL0041 WL0042 WL0043 WL0044 WL0045 WL0046 WL0045A WL0049 WL0049A WL0051 WL0051A WL0052 WL0053 WL0055 WL0056 WL0057 WL0057A WL0059 WL0060 WL0061 WL0061A WL0062 WL0062A WL0061A WL0063 WL0062B WL0064 WL0065 WL0067 WL0069 WL0070 WL0071 WL0066A WL0068A WL0072 WL0073 WL0074 WL0075 WL0076 WL0078 WL0079 WL0080 WL0081 WL0076A WL0082 WL0083 WL0084 WL0088 WL0089A WL0091 WL0090 WL0093 WL0097 WL0098 WL0099 WL0101 WL0102 WL0105 WL0106 WL0108 WL0111 WL0111A WL0113 WL0117 WL0118
ClassificationClass II
Reason for RecallThe recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result which will be the only value reported.
Product Quantity26,075 units
Recall NumberZ-1853-2012
Product DescriptionVerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Code InfoNot available
ClassificationClass II
Reason for RecallThe recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result which will be the only value reported.
Product Quantity1,167 units total
Recall NumberZ-1854-2012

Class II Food Event

Event ID61867
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCasa De Mesquite Llc
CityHollister
StateCA
CountryUS
Distribution PatternProduct was released for distribution in US and Canada.
 

Associated Products

Product DescriptionCasa de Mesquite brand Mesquite Bean Flour, packaged in 10 kg bag in carton, and 13 kg bag in carton for food manufacturing, and 10, 24 and 44 oz retail bags; Product is processed and packaged by Casa de Mesquite, LLC, Hollister, CA
Code InfoLot #: 123001
ClassificationClass II
Reason for RecallRecent tests show that one lot of this product has the potential to be contaminated with bacillus cereus, a spoilage organism which can cause diarrhea, nausea and other symptoms.
Product Quantity375 x 13 kg cartons
Recall NumberF-1453-2012

Class II Devices Event

Event ID61868
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNon-Invasive Monitoring Systems, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionUS-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure
Code InfoBrochure US-001 Rev A
ClassificationClass II
Reason for RecallNon-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Product QuantityUS-001 Rev A brochure: 3665
Recall NumberZ-1819-2012
Product DescriptionUSA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure
Code InfoBrochure USA-002 Rev A
ClassificationClass II
Reason for RecallNon-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Product QuantityUSA-002 Rev A brochure: 91
Recall NumberZ-1820-2012

Class II Devices Event

Event ID61877
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution Pattern6 US customers
 

Associated Products

Product DescriptionPhilips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Code InfoAll systems with Eleva software version 4.x and stitching option.
ClassificationClass II
Reason for RecallIf a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be executed unnecessarily. Usability is identified to be the main contributing factor.
Product Quantity6
Recall NumberZ-1821-2012

Class II Drugs Event

Event ID61878
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Laboratories
CityAbbott Park
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionZemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
Code InfoLot #: 11-122-DK, Exp 10/13
ClassificationClass II
Reason for RecallCGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Product Quantity121,000 vials
Recall NumberD-1388-2012

Class II Devices Event

Event ID61913
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpacelabs Healthcare, Llc
CityIssaquah
StateWA
CountryUS
Distribution PatternWorldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM.
 

Associated Products

Product DescriptionThe product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
Code InfoVersion 1.6.0.
ClassificationClass II
Reason for RecallThe firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.
Product Quantity114
Recall NumberZ-1831-2012

Class II Drugs Event

Event ID61917
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmLinde Gas LLC
CityColumbus
StateOH
CountryUS
Distribution PatternDistributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.
 

Associated Products

Product DescriptionLifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
Code InfoLOT#: 117H201 LOT#: 117H202
ClassificationClass II
Reason for Recall CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
Product Quantity283 cylinders
Recall NumberD-1383-2012

Class II Devices Event

Event ID61926
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BENIN BHUTAN BOLIVIA BOSNIA&HERZEGOVINA BRAZIL BRUNEI DARUSSALAM BULGARIA BURUNDI CAMBODIA CAMEROON CANARY ISLANDS CHAD CHILE CHINA COLOMBIA CONGO CONGO,DEMOCRATIC COSTA RICA COTE D'IVOIRE CROATIA CUBA CYPRUS CZECH REPUBLIC DENMARK DJIBOUTI DOMINICAN REPUBLIC ECUADOR EGYPT EL SALVADOR EQUATORIAL GUINEA ERITREA ESTONIA ETHIOPIA fake test ssd FINLAND FRANCE FRENCH GUIANA GABON GAMBIA GEORGIE GERMANY GHANA GREECE GUADELOUPE GUAM GUATEMALA GUINEA GUYANA HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKSTAN KENYA KUWAIT KYRGYZSTAN LAO PEOPLE'S DEM.REP LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRI LIECHTENSTEIN LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAWI MALAYSIA MALI MALTA MARTINIQUE MAURITANIA MAURITIUS METRACOM MEXICO MOLDOVA MONGOLIA MOROCCO MOZAMBIQUE NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORTH KOREA NORWAY OMAN PAKISTAN PALESTINE PANAMA PARAGUAY PERU PHC BEST PHILIPPINES PMCC BU Canada PMCC BU USA POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA&MONTE NEGRO SIERRA LEONE SINGAPORE SLOVAKIA SLOVENIA SOMALIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SUDAN SURINAME SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN TAJIKISTAN TANZANIA THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE Unidentified Country UNITED ARAB EMIRATES UNITED KINGDOM URUGUAY UZBEKISTAN VENEZUELA VIET NAM YEMEN ZAMBIA ZIMBABWE
 

Associated Products

Product DescriptionPhilips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Code InfoSoftware release 2.0.2 and 2.0.2SP1 including mirror icon
ClassificationClass II
Reason for RecallWith Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "right patient side" marker, although this can appear on the left patient side
Product Quantity752 units
Recall NumberZ-1818-2012

Class II Devices Event

Event ID61935
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBoston Scientific Corporation
CityMarlborough
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
 

Associated Products

Product DescriptionBoston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Code InfoLot Numbers: 14951476, 14951479, 14987882,15068203
ClassificationClass II
Reason for RecallDifficulty in extending snare loop from the catheter
Product Quantity2760 units
Recall NumberZ-1850-2012
Product DescriptionBoston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Code InfoLot Numbers: 14951482, 14951484, 15068143
ClassificationClass II
Reason for RecallDifficulty in extending snare loop from the catheter
Product Quantity1970 units
Recall NumberZ-1851-2012
Product DescriptionBoston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Code InfoLot Number: 14974048
ClassificationClass II
Reason for RecallDifficulty in extending snare loop from the catheter
Product Quantity1340 units
Recall NumberZ-1852-2012

Class II Devices Event

Event ID61942
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCovidien LP
CityNorth Haven
StateCT
CountryUS
Distribution PatternWorldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPAÑA France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK.
 

Associated Products

Product Description Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code InfoLOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
ClassificationClass II
Reason for RecallPotential for the sterility barrier to be compromised.
Product Quantity50698 units
Recall NumberZ-1844-2012
Product DescriptionCovidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code InfoLOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
ClassificationClass II
Reason for RecallPotential for the sterility barrier to be compromised.
Product Quantity13531 units
Recall NumberZ-1845-2012
Product DescriptionCovidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code InfoLOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
ClassificationClass II
Reason for RecallPotential for the sterility barrier to be compromised.
Product Quantity13531 units
Recall NumberZ-1846-2012
Product DescriptionCovidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code InfoLOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
ClassificationClass II
Reason for RecallPotential for the sterility barrier to be compromised.
Product Quantity28248 units
Recall NumberZ-1847-2012
Product DescriptionCovidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code InfoLOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
ClassificationClass II
Reason for RecallPotential for the sterility barrier to be compromised.
Product Quantity17848 units
Recall NumberZ-1848-2012

Class II Devices Event

Event ID61946
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNatus Medical Incorporated
CitySeattle
StateWA
CountryUS
Distribution PatternWorldwide Distribution -- USA (nationwide) including the states of : AK; AR; AZ; CA; CO; DE; FL; GA; HI; ID; IL; IN; KY; MA; MI; MN; MS; ND; NE; NJ; NY; OH; PA; SC; SD; TN; TX; and WA. and the countries of : Argentina; Australia; Austria; Canada; Egypt; Germany; Hong Kong; Indonesia; Iran; Italy; Kuwait; Poland; Russia; Saudi Arabia; Singapore; Slovenia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey; United Arab Emirates; and United Kingdom.
 

Associated Products

Product DescriptionOlympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"
Code InfoCooling Serial Numbers: 1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1030; 1031; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1080; 1081; 1082; 1083; 1085; 1086; 1087; 1088; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1101; 1116; 1117; 1118; 1119; 1120; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7013; 7014; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7265; 7266; 7267; 7268; 7269; 7270; 7271; 7272; 7273; 7274; 7275; 7276; 7277; 7278; 7279; 7280; 7281; 7282; 7283; 7284; 7285; 7286; 7288; 7289; 7290; 7291; 7292; 7293; 7294; 7363; 7364; 7365; 7366; 7372; and 7374.
ClassificationClass II
Reason for RecallOlympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
Product Quantity181 units
Recall NumberZ-1843-2012

Class II Drugs Event

Event ID61960
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmKutol Products Co Inc
CityCincinnati
StateOH
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionHands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
Code InfoLot #: 090204012 , 090303026 , 090508009 , 090604024 , 090725030 , 090829002, 091005017 , 091223002 , 100115022 , 100316005 , 100115022 , 100316005,100329004 , 100607017 , 100730001 , 100817014 , 100921018 , 101020009, 101208003 , 101218007 , 110405009 , (L)11053105 , (L)11062811 , (L)11081805, and (L)11091206
ClassificationClass II
Reason for RecallLabeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.
Product Quantity11,688 gallon bottles (2,922 cases)
Recall NumberD-1387-2012

Class II Food Event

Event ID61999
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOcean Group Inc.
CityLos Angeles
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionTiny IQF Oysters, 40pk/cs, 8oz.
Code InfoLot#10997L
ClassificationClass II
Reason for RecallOcean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity187 units
Recall NumberF-1440-2012
Product DescriptionLarge IQF Oysters, 6 x 4 lb/cs
Code InfoLot#11801
ClassificationClass II
Reason for RecallOcean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity113 units
Recall NumberF-1441-2012
Product DescriptionHalf Shell Oysters, 144pc/cs
Code InfoLot#209003, 208497, 209628, 209683
ClassificationClass II
Reason for RecallOcean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity240 units
Recall NumberF-1442-2012

Class II Food Event

Event ID62019
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmKerry Foods
CityBeloit
StateWI
CountryUS
Distribution PatternAZ, CA, MN, NV, NC, OR, IL, IN, MO, NE, OH, PA, TN, TX, WI. CANADA, CHILE
 

Associated Products

Product DescriptionKERRY, 4 CHEESE SEAS 30506103, CONTAINS MILK, Net Wt 50 Lb (22.68 Kg), Item Number 30506103.465
Code Info0502206602
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity298 BG
Recall NumberF-1477-2012
Product DescriptionKERRY, WHITE CHEDDAR SNACK SEASONING, CONTAINS MILK, Item Number 6000654.01, Net Wt 50 Lb (22.68 Kg)
Code Info0426260104
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity98 BG
Recall NumberF-1478-2012
Product DescriptionKERRY, CREAMY PARMESAN SEASONING, CONTAINS MILK, Item Number 62310.01, Net Wt 50 Lb (22.68 Kg)
Code Info0426276401 -0426276404
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity401 CT
Recall NumberF-1479-2012
Product DescriptionKERRY, CHEDDAR CHEESE, CONTAINS MILK, 701183, R-SE-0056 , Item Number 701183.465, Net Wt 50 Lb (22.68 Kg)
Code Info0420276603
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity39 CT
Recall NumberF-1480-2012
Product DescriptionKERRY, NACHO SEAS 0686, Contains Milk, Wheat, Net Wt 22.68 KG (50 lb), Item Number 10686.482
Code Info0412206603, 0503206601
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity810 BG
Recall NumberF-1481-2012
Product DescriptionKERRY, CHEESE BLEND 77, 1150020, CONTAINS MILK AND SOY, Item # 17980.465, Net Wt 50 Lb (22.68 Kg)
Code Info0503206602
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity40 BG
Recall NumberF-1482-2012
Product DescriptionKERRY, PARM. LING. 5734, SEA 5734, CONTAINS MILK, Item # 15734.607, , Net Wt 1000 Lb (453.556 Kg)
Code Info0409258004
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity4.52 TT
Recall NumberF-1483-2012
Product DescriptionKERRY, LASAGNA SKLT SEAS 10078, SE10078, CONTAINS MILK, Item # I10078.859, Net Wt 1600 Lb (725.69Kg)
Code Info0423205406
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity4 TT
Recall NumberF-1484-2012
Product DescriptionKERRY, CHEDDAR & SOUR CREAM 1037, CONTAINS MILK, Item # 717519.360, Net Wt 25 Lb (11.34Kg)
Code Info0402276402 0402276403 0402276404 0502276401 0502276402 0502276403
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity957 BG
Recall NumberF-1485-2012
Product DescriptionKERRY, THREE CHEESE MINI SHELLS 10109, CH10109 , CONTAINS MILK, CH718592 Item Number I10109.859, Net Wt 1600 Lb (725.69 Kg)
Code Info0417258001
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity7.647 TT
Recall NumberF-1486-2012
Product DescriptionKERRY, PARMESAN ASIAGO TYPE SEASONING, CONTAINS MILK, Item # 718622.465, Net Wt 50 Lb (22.68 Kg)
Code Info0509257903
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity41 BG
Recall NumberF-1487-2012
Product DescriptionKERRY, CHEDDAR & SOUR CREAM 725775, CONTAINS MILK, Item # 725775.465, Net Wt 50 Lb (22.68 Kg)
Code Info0423223803
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity41 BG
Recall NumberF-1488-2012
Product DescriptionKERRY, SOUR CR 7 CHIVES 718948, S37ASC, CONTAINS MILK, WHEAT, Item # 718948.465, Net Wt 50 Lb (22.68 Kg)
Code Info0430257902
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity145
Recall NumberF-1489-2012
Product DescriptionKERRY, THICK & CHEESY 0601, CH0601, CONTAINS MILK, Item Number 10601.859, Net Wt 1600 Lb (725.69 Kg)
Code Info0424205403
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity5 TT
Recall NumberF-1490-2012
Product DescriptionKerry, NO MSG CHED SC SEAS 01113, CONTAINS MILK, Item # 720061.465, Net Wt 50 Lb (22.68 Kg)
Code Info0511224104
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity41 BG
Recall NumberF-1491-2012
Product DescriptionKerry, PARMESAN BLEND 720068 CH720068, CONTAINS MILK, WHEAT, Item # 720068.607, Net Wt 1000 Lb (453.556 Kg)
Code Info0430258003
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity3 TT
Recall NumberF-1492-2012
Product DescriptionKerry, CREAMY PARMESAN SEAS S57CP, CONTAINS MILK, WHEAT, Item # 720104.465, Net Wt 50 Lb (22.68 Kg)
Code Info0410257905
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity41 BG
Recall NumberF-1493-2012
Product DescriptionKerry, CREAMY ITALIAN SEASONING S57CIT, CONTAINS MILK, Item # 720109.465, Net Wt 50 Lb (22.68 Kg)
Code Info0507257904
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity42 BG
Recall NumberF-1494-2012
Product DescriptionKERRY, CHEDDAR BROCCOLI SEAS S25CBROC, CONTAINS MILK, Item # 720175.465, Net Wt 50 Lb (22.68 Kg)
Code Info0504257903
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity41 TT
Recall NumberF-1495-2012
Product DescriptionKERRY, CREAMY GARLIC 720721 S25CG, CONTAINS MILK, SOY, WHEAT, Item # 720721.465, Net Wt 50 Lb (22.68 Kg)
Code Info0504257902
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity41 BG
Recall NumberF-1496-2012
Product DescriptionKERRY, PARM GARLIC 720850 R-SE-0152, CONTAINS MILK, Item # 720850.470, Net Wt 50 Lb (22.68 Kg)
Code Info0510276401, 0426276602
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity120 CT
Recall NumberF-1497-2012
Product DescriptionKERRY, BACON 7 RANCH SEAS 720943 SE720943, CONTAINS MILK, SOY, WHEAT, Item # 720943.859, Net Wt 1600 Lb (725.69 Kg)
Code Info0416258002 0504258001 0507258003
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity5.367 TT
Recall NumberF-1498-2012
Product DescriptionKERRY, STROGANOFF SEAS 10079 SE10079, CONTAINS MILK, WHEAT, Item # I10079.859, Net Wt 1600 Lb (725.69 Kg)
Code Info0427205402
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity11 TT
Recall NumberF-1499-2012
Product DescriptionKERRY, NACHO SEAS NAT, CONTAINS MILK, Item # 721108.465, Net Wt 50 Lb (22.68 Kg)
Code Info0504224104
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity40 bg
Recall NumberF-1500-2012
Product DescriptionKERRY, WHITE CHEDDAR SEAS 10230 SE10230, CONTAINS MILK, WHEAT, Item # I10230.859, Net Wt 1600 Lb (725.69Kg)
Code Info0426258001
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity4 TT
Recall NumberF-1501-2012
Product DescriptionKERRY, BUFFALO WING SEASONING , Item # I10256.465, Net Wt 50 Lb (22.68 Kg)
Code Info0507275301
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity100 BG
Recall NumberF-1502-2012
Product DescriptionKERRY, CULTURED NF BUTTERMILK 986, CODE 031001.010, CONTAINS MILK, Item # I2868.465 , Net Wt 50 Lb (22.68 Kg)
Code Info0416205402 0417205401 0418205401
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity2400 BG
Recall NumberF-1503-2012
Product DescriptionKERRY, MELOBLEND 2237 code: d 1.29 edible, CONTAINS MILK, Item # I7097.465, Net Wt 50 Lb (22.68 Kg)
Code Info0418205403
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity44 BG
Recall NumberF-1504-2012
Product DescriptionKERRY, BUTTERMILK 987 CONTAINS MILK, Item # I2993.465, Net Wt 50 Lb (22.68 Kg)
Code Info0419205403
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity111 bg
Recall NumberF-1505-2012
Product DescriptionKERRY, AU GRATIN SEAS 722912, CONTAINS MILK, WHEAT, Item # 722912.465, Net Wt 50 Lb (22.68 Kg)
Code Info0502206603
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity200 bg
Recall NumberF-1506-2012
Product DescriptionKERRY, ONION RING SEAS 18125 , CONTAINS MILK, Item # B18125.01, Net Wt 50 Lb (22.68 Kg)
Code Info0503224101
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity240 BG
Recall NumberF-1507-2012
Product DescriptionKERRY, STROGANOFF SEAS 722920 SE722920, CONTAINS MILK, WHEAT, Item # 722920.859, Net Wt 1600 Lb (725.69 Kg)
Code Info0427205401
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity6 BG
Recall NumberF-1508-2012
Product DescriptionKERRY, MAC 7 CHS SAUCE MIX 723357 CH723357, CONTAINS MILK, WHEAT, Item # 723357.859, Net Wt 1600 Lb (725.69 Kg)
Code Info0410258001 0416258001
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity40 TT
Recall NumberF-1509-2012
Product DescriptionKERRY, BACON RANCH SEAS 723951 S57RB, CONTAINS MILK, Item # 723951.465, Net Wt 50 Lb (22.68 Kg)
Code Info0410257904 0508257901
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity112 BG
Recall NumberF-1510-2012
Product DescriptionKERRY, SALSA FRESCA 725058, Item # 725058.465, Net Wt 50 Lb (22.68 Kg)
Code Info0426276601
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity40 BG
Recall NumberF-1511-2012
Product DescriptionKERRY, ITALIAN PASTA SALAD SEASONING, Item # 725445.859, Net Wt 1600 Lb (725.69 Kg)
Code Info0430258002
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity10 TT
Recall NumberF-1512-2012
Product DescriptionKERRY, GOLDEN CHEDDAR CHEESE 716932 , R-SE-0132, CONTAINS MILK, Item # 716932.465, Net Wt 50 Lb (22.68Kg) KERRY, R-SE-0132TM, CONTAINS MILK, Item # 716932.TM, Net Wt 50 Lb (22.68Kg)
Code Info0510276403 0424276403
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity178 CT
Recall NumberF-1513-2012
Product DescriptionKERRY, SEA SALT & VINEGAR 722536 R-SE-0155, , Item # 722536.440, Net Wt 40 Lb (18.14 Kg) KERRY, R-SE-0155TM, , Item # 722536.TM, Net Wt 40 Lb (18.14 Kg)
Code Info0420276401 0420276402 0420276403 0426275303 0426275302
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity400 CT
Recall NumberF-1514-2012
Product DescriptionKERRY, MOZZARELLA SESONING - NO PHSO, CONTAINS MILK, SOY, Item # I10187.465 , Net Wt 50 Lb (22.68Kg)
Code Info0502224108
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity 82.000 BG
Recall NumberF-1515-2012
Product DescriptionKERRY, ROASTED GARLIC SEAS 10112, S37RG2 , CONTAINS MILK, SOY, Item # I10112.465, Net Wt 50 Lb (22.68Kg)
Code Info0410206604
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity362.000 BG
Recall NumberF-1516-2012
Product DescriptionKERRY, DOUBLE CHEESEBURGER SEAS 8917 , S20DC, CONTAINS MILK, WHEAT, Item #I8917.465, Net Wt 50 Lb (22.68Kg)
Code Info0417258002
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity 164.000 BG
Recall NumberF-1517-2012
Product DescriptionKERRY, SOUR CRM & CHIVES 0989 S37SCC, CONTAINS MILK, , Item #I0989.465 , Net Wt 50 Lb (22.68Kg)
Code Info0510257902
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity 106.000 BG
Recall NumberF-1518-2012
Product DescriptionKERRY, CHEESEBURGER SEAS 8543, S20C3, CONTAINS MILK,WHEAT , Item #I8543.465 , Net Wt 50 Lb (22.68Kg)
Code Info0430205403
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity 408.000 BG
Recall NumberF-1519-2012
Product DescriptionKERRY, KF PART # 117404 , CONTAINS MILK, Item #I10389.02 , Net Wt 50 Lb (22.68Kg)
Code Info0426223810 0420223803
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity327 BG
Recall NumberF-1520-2012
Product DescriptionKERRY, KF # 11605R, CONTAINS MILK, Item #B18648.02 , Net Wt 50 Lb (22.68Kg)
Code Info0502224105
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity80.000 BG
Recall NumberF-1521-2012
Product DescriptionKERRY, KF # 10987R, CONTAINS MILK, Item #B16903.01, Net Wt 50 Lb (22.68Kg)
Code Info0509224102
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity40 BG
Recall NumberF-1522-2012
Product DescriptionKERRY, CHEDDAR BEER TYPE 725554 , CONTAINS MILK, Item #725554.465, Net Wt 50 Lb (22.68Kg)
Code Info0423223802
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity40 BG
Recall NumberF-1523-2012
Product DescriptionKERRY, BATTER G3668, 1520374, CONTAINS MILK AND WHEAT, Item #G3668.MC1, Net Wt 50 Lb (22.68Kg)
Code Info0404216007
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity36.000 BG
Recall NumberF-1524-2012
Product DescriptionKERRY, HOT CHEESE, SEAS, 04-20200, CONTAINS MILK , Item #I10185.465, Net Wt 50 Lb (22.68Kg)
Code Info0426258003
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity35 CT
Recall NumberF-1525-2012
Product DescriptionKERRY, NACHO SEASONING 717379, 04-20200, CONTAINS MILK , SOY, Item # 717379.465, Net Wt 50 Lb (22.68Kg)
Code Info0425260117
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity394 BG
Recall NumberF-1526-2012
Product DescriptionKERRY, CHEESE BLEND 862B , CONTAINS MILK Item # I2065.465, Net Wt 50 Lb (22.68Kg)
Code Info0426257901
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity42 BG
Recall NumberF-1527-2012
Product DescriptionKERRY, CHEESE SEASONING 15704, CONTAINS MILK, Item # B15704.01, Net Wt 50 Lb (22.68Kg)
Code Info0504224103 0504224102
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity493 BG
Recall NumberF-1528-2012
Product DescriptionKERRY, CHEESY CHEDDAR SEAS I10103, CONTAINS MILK, SOY, Item # I10103.465, Net Wt 50 Lb (22.68Kg)
Code Info0511223806
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity238 BG
Recall NumberF-1529-2012
Product DescriptionKERRY, JALAPENO CHEDDAR 16975, GCAS# 95546689, CONTAINS MILK, Item # B16975.01, Net Wt 50 Lb (22.68Kg)
Code Info0430223802 0430223803
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity391 BG
Recall NumberF-1530-2012
Product DescriptionKERRY, CHEZ-TONE 6313, QO-05424 / QO-2200542400, CONTAINS MILK, Item # I6313.465, Net Wt 50 Lb (22.68Kg)
Code Info0410206601
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity401 BG
Recall NumberF-1531-2012
Product DescriptionKERRY, MELOBLEND 737, CODE:QO-05358, CONTAINS MILK, Item # I7126.465, Net Wt 50 Lb (22.68Kg)
Code Info0416205401
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity400 BG
Recall NumberF-1532-2012
Product DescriptionKERRY, PL BROC & CHEESE SEAS 8893 , CONTAINS MILK, WHEAT, Item # I8893.465, Net Wt 50 Lb (22.68Kg)
Code Info0419258001
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity204 BG
Recall NumberF-1533-2012
Product DescriptionKERRY, MELOBLEND 1048, 95317, CONTAINS MILK, Item # I7067.465, Net Wt 50 Lb (22.68Kg)
Code Info0420205403
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity896 BG
Recall NumberF-1534-2012
Product DescriptionKERRY, PARMESAN AND SUNDRIED TOMATO SEASONING, CONTAINS MILK, Item # B18122.01, Net Wt 50 Lb (22.68Kg)
Code Info0508276601
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity40 BG
Recall NumberF-1535-2012
Product DescriptionKERRY, HOT BUFFALO WINGS PRETZEL SEAS 173211, Item # B16413.01, Net Wt 44.5 Lb (20.18 kg)
Code Info0424223803 0424223804 0502223801 0502223802
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity1309 BG
Recall NumberF-1536-2012
Product DescriptionKERRY, SOUR CREAM AND ONION 10286, CONTAINS MILK, Item # I10286.465, Net Wt 50 Lb (22.68 Kg)
Code Info0430275306 0430275307 0430275304 0430275305 0430275308 0430275301 0430275302
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity560 BG
Recall NumberF-1537-2012
Product DescriptionKERRY, PARM GARLIC SEAS 721221, CONTAINS MILK, Item # 721221.399 & 721221.398 , Net Wt 50 Lb (22.68 Kg)
Code Info0426223807
ClassificationClass II
Reason for RecallKerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity60 BG
Recall NumberF-1538-2012

Class II Devices Event

Event ID62052
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Australia Austria Belgium Bharain Canada China Columbia Czech Republic Denmark Dutch Antilles Egypt Estonia Finland France Germany Hong Kong Ireland Israel Italy Latvia Lebanon Luxembourg Malaysia Mexico Netherlands New Zealand Norway Philippines Qatar Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom
 

Associated Products

Product DescriptionPhilips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography
Code InfoUnits with cable swivel delivered from 2007
ClassificationClass II
Reason for RecallMultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
Product Quantity433 units
Recall NumberZ-1829-2012

Class II Devices Event

Event ID62120
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUltradent Products, Inc.
CitySouth Jordan
StateUT
CountryUS
Distribution PatternWorldwide Distribution.
 

Associated Products

Product DescriptionPeak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
Code InfoLot number: B6Z4K.
ClassificationClass II
Reason for RecallUltradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.
Product Quantity172 kits (4 syringes per kit)
Recall NumberZ-1822-2012

Class II Devices Event

Event ID62125
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmArrow International Inc
CityReading
StatePA
CountryUS
Distribution PatternUSA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.
 

Associated Products

Product DescriptionArrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
Code InfoLot number RF2033361
ClassificationClass II
Reason for RecallArrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
Product Quantity1,085
Recall NumberZ-1823-2012

Class II Devices Event

Event ID62127
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGenzyme Corporation
CityFramingham
StateMA
CountryUS
Distribution PatternWorldwide Distribution - US (nationwide) and the country of S. Korea
 

Associated Products

Product Descriptionseprafilm® Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Code InfoLot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
ClassificationClass II
Reason for RecallSterility of product may be compromised due to packaging defect
Product Quantity3880units
Recall NumberZ-1855-2012
Product Descriptionseprafilm® Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Code InfoLot number: 11NP685 . Exp 2014- 11
ClassificationClass II
Reason for RecallSterility of product may be compromised due to packaging defect
Product Quantity1285 units
Recall NumberZ-1856-2012

Class II Devices Event

Event ID62130
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Dec-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionStryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.
Code Info510K exempt Catalog Number 1020-1400 Lot Code P5E93
ClassificationClass II
Reason for RecallStryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Product Quantity41 units
Recall NumberZ-1816-2012

Class II Drugs Event

Event ID62239
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPhysicians Total Care, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternAK, NC, GA
 

Associated Products

Product DescriptionLipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0
Code InfoLots 6284, 60DI, 61AA.
ClassificationClass II
Reason for RecallChemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
Product Quantity3 bottles
Recall NumberD-1389-2012

Class II Food Event

Event ID62273
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jun-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmWoosung America Corp.
CityHayward
StateCA
CountryUS
Distribution PatternNorthern CA only.
 

Associated Products

Product DescriptionFrozen Oysters: 1) CHORIPDONG) FROZEN OYSTER, IQF 8OZ*40; 2) CJ FOOD, INC.)FROZEN OYSTER 8oz*40; Not for Retail Sale, Must be fully cooked before serving. Distributed by CJ Foods, Inc., Commerce, CA; 3) JAYONE FOODS, INC.) FROZEN OYSTER 8 oz*40, IQF, Distributed by Jayone Foods, Inc.., Paramount, CA 92723 Product of Korea
Code Info1) Item number 3137810; 2) Item number 2237840; 3) Item number 36037800
ClassificationClass II
Reason for RecallThe product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantitynot provided
Recall NumberF-1444-2012
Product DescriptionHONG CHANG)OYSTER MEAT 8 oz*40
Code InfoItem number 2137845
ClassificationClass II
Reason for RecallThe product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantitynot provided
Recall NumberF-1445-2012
Product DescriptionOCEAN GREEN)OYSTER LARGE 5lb*6, IQF Imported by: J & S Group 2535E 12th St. #B Los Angeles, CA 90021
Code InfoItem number oys0070
ClassificationClass II
Reason for RecallThe product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantitynot provided
Recall NumberF-1448-2012
Product DescriptionPACIFIC GIANT) OYSTERS,IQF,KOREA 8 oz*40 Imported by Pacific Giant, Vernon, CA 90058 Product of Korea
Code InfoItem number 6537880
ClassificationClass II
Reason for RecallThe product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantitynot provided
Recall NumberF-1449-2012

Class II Food Event

Event ID62275
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSonora Mills Foods
CityEast Rancho Dominguez
StateCA
CountryUS
Distribution PatternUS Nationwide and Canada
 

Associated Products

Product Descriptionpopchips® Cheddar Potato, Popped Chip Snack, 0.8 oz, UPC 0 82666 78800 3
Code InfoLot MAY2613, MAY2913TM
ClassificationClass II
Reason for RecallThe firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments.
Product Quantity567 cases
Recall NumberF-1631-2012
Product Descriptionpopchips® Sea Salt & Vinegar, Potato Popped Chip Snack, 0.4 oz (UPC 0 82666 76550 9), 0.8 oz (UPC 0 82666 75500 5), 3 oz (UPC 0 82666 70050 0), 85 g (UPC 0 82666 71240 4 and 0 82666 71240 4)
Code Info0.4oz: MAY2113; 0.8 oz: Lot MAY1613, MAY2013, MAY2113TM, MAY2613; 3 oz: MAY0313, MAY0813, MAY0913, MAY1013LY, MAY1513, MAY1613, MAY2113, MAY2113TM; 85g: Lot 13MA23TM and 13MA08
ClassificationClass II
Reason for RecallThe firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments.
Product Quantity17586 cases
Recall NumberF-1632-2012
Product DescriptionCheddar Mini Rice Snacks under the following brand names: Fred Meyer, 3 oz, UPC 0 11110 90004 3; Kroger, 3 oz, UPC 0 11110 35789 2; Ralphs, 3 oz, UPC 0 11110 91220 9; Safeway, 3 oz. UPC 0 21130 29808 2;
Code InfoLot FEB 19 13
ClassificationClass II
Reason for RecallThe firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments.
Product Quantity2395 cases
Recall NumberF-1633-2012

Class II Food Event

Event ID62303
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTrue World Foods San Francisco LLC.
CitySan Leandro
StateCA
CountryUS
Distribution PatternRestaurants in Northern Ca only.
 

Associated Products

Product DescriptionOyster Frozen Half Shell; 144 Pc/CS Processed by: Dai One Food Co., LTD #150 Jun-RI, Sanyang-UP Tongyeong-City Kyungsangnam-DO. to: Khee Trading, Vernon, CA 90058.
Code InfoCode number OYS0300
ClassificationClass II
Reason for RecallThe product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantitynot provided
Recall NumberF-1437-2012
Product DescriptionFrozen Oyster Meat IQF (Z4) 4 lb box Packed by Dong Won Mul San Co. Tongyeong-City, Gyeongsangnam-Do. Imported by Ayana Group, Inc. Washington, CA
Code InfoCode number OYS0550
ClassificationClass II
Reason for RecallThe product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantitynot provided
Recall NumberF-1438-2012
Product DescriptionBreaded Oyster Large Size
Code InfoCode number OYS0800
ClassificationClass II
Reason for RecallThe product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity
Recall NumberF-1439-2012

Class II Food Event

Event ID62339
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRed Chamber Company
CityVernon
StateCA
CountryUS
Distribution PatternCalifornia and Floria
 

Associated Products

Product DescriptionFrozen Korean Oyster Meat I.Q.F.: , 1) 40x8oz., UPC 19964 30091; 2) 1x25lbs, .; 3) 5x4lbs.UPC 19964 30092
Code Info1) lot#138338P; 2) lot#138339-P; 3) lot #138340-P
ClassificationClass II
Reason for RecallRed Chambers is recalling Dai One Food Oyster IQF 4lbs, 25 lbs, and 8 oz because the products have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity1) 83 units; 2) 800 units; 3) 13 units
Recall NumberF-1542-2012

Class III Devices Event

Event ID61737
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTripath Imaging, Inc.
CityBurlington
StateNC
CountryUS
Distribution PatternWorldwide Distribution.
 

Associated Products

Product DescriptionPrepStain Syringing Pipettes 240 (Catalog #490517)
Code Info100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r
ClassificationClass III
Reason for Recall The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity46,112,784 for all products in Recall Event
Recall NumberZ-1811-2012
Product DescriptionPrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Code Info100903ra, 100903rb, 100903rf, 100903rj, 100903rn, 100903rr, 100903rt, 100903rx, 100903sb, 100903sc, 100903sd, 100903se, 100903sf, 100903sl, 100910rd, 100910re, 100910rh, 100910rp, 100910rq, 100910rr, 100917rb, 100917rh, 100917rk, 100917rp, 100917rr, 100917ru, 100917sa, 100917sc, 100917se, 100924ra, 100924ri, 100924rj, 100924rl, 100924rn, 100924rp, 100924rs, 100924rt, 100924ry, 101001ra, 101001rb, 101001rc, 101001rh, 101001rm, 101001rq, 101001ru, 101001rv, 101001rw, 101001ry, 101001rz, 101008ra, 101008rb, 101008rf, 101008rg, 101008rh, 101008ri, 101008rq, 101008rr, 101008rw, 101008rx, 101008sa, 101008sc, 101008sd, 101008se, 101008sf, 101008sg, 101008sh, 101015rh, 101015rk, 101015rr, 101015rw, 101015rx, 101015sd, 101015se, 101015sf, 101015sg, 101022re, 101022rp, 101022rq, 101022sb, 101022si, 101022sk, 101022sl, 101022so, 101022sr, 101022su, 101029ra, 101029rd, 101029re, 101029rh, 101029ri, 101029rx, 101029sc, 101029sd, 101029sf, 101029sk, 101029ss, 101029st, 101105rl, 101105rm, 101105rt, 101105sb, 101105sd, 101105se, 101105sf, 101105sk, 101105sl, 101105so, 101105ss, 101112ra, 101112re, 101112rl, 101112rt, 101112ru, 101112rv, 101112rz, 101112sa, 101112sf, 101112sg, 101112si, 101112sw, 101112sx, 101119ra, 101119ri, 101119rj, 101119rr, 101119ru, 101119rx, 101119ry, 101119rz, 101119sh, 101119sl, 101119so, 101126ra, 101126rg, 101126rl, 101203ra, 101203rb, 101203rc, 101203rd, 101203rh, 101203rj, 101203rp, 101203rr, 101203rs, 101203ru, 101203rw, 101203si, 101203sl, 101203sn, 101203so, 101203sp, 101210rg, 101210rh, 101210rk, 101210rl, 101210ru, 101210rv, 101210rx, 101210sa, 101210sj, 101217ra, 101217rc, 101217rh, 101217rm, 101217rn, 101217rp, 101217rt, 101217rw, 101217rx, 101224rd, 101224re, 101224rg, 101224rk, 101224rl, 101224rt, 101224ru, 101224rv, 101224rw, 101231rc, 101231rd, 101231rg, 101231rh, 101231ri, 101231rj, 101231ro, 101231rp, 110107rh, 110107ri, 110107rk, 110107rp, 110107rq, 110107rr, 110107rz, 110107sb, 110107sc, 110114rf, 110114rg, 110114rv, 110114rw, 110114rx, 110114ry, 110114sj, 110114sk, 110114sm, 110121rd, 110121rn, 110121rq, 110128rd, 110128rp, 110128rq, 110128rx, 110128sb, 110128sc, 110128sg, 110128sl, 110128sn, 110128sp, 110128sq, 110204ra, 110204rd, 110204rg, 110204rj, 110204rq, 110204rv, 110204rx, 110204sd, 110211rb, 110211rd, 110211rg, 110211rj, 110211rn, 110218rw, 110225rk, 110225rl, 100917rc, 101015sb, 101119sg, 101217ro, 110114sc, 110128sk
ClassificationClass III
Reason for Recall The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity46,112,784 for all products in Recall Event
Recall NumberZ-1812-2012
Product DescriptionPrepStain Installation Kit (PreCoat), Catalog/Model # 490528
Code Info100917ry, 101105sh, 110107rg
ClassificationClass III
Reason for Recall The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity46,112,784 for all products in Recall Event
Recall NumberZ-1813-2012
Product DescriptionManual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Code Info100903ru, 100924rr, 101022sc, 110114sh, 110225ru
ClassificationClass III
Reason for Recall The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity46,112,784 for all products in Recall Event
Recall NumberZ-1814-2012
Product DescriptionPrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
Code InfoThis is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r
ClassificationClass III
Reason for Recall The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity46,112,784 for all products in Recall Event
Recall NumberZ-1815-2012

Class III Drugs Event

Event ID61759
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionJolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Code InfoLot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013
ClassificationClass III
Reason for RecallContraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Product Quantity40,750 Dispensers
Recall NumberD-1384-2012

Class III Food Event

Event ID61937
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmLA Link Corporation
CityCerritos
StateCA
CountryUS
Distribution PatternDistributed to retail in the following states: HI, NV, CA
 

Associated Products

Product DescriptionShiitake-Ya brand Dried Shiitake mushroom slices, 6 oz plastic jars, UPC 7 1452 22183 9. Product labeling reads in part: " Shiitake-Ya gourmet Shiitake SLICES***Antioxidants Amino Acids Omega 3+6***Immune-Boosting*** NET WEIGHT. 6 oz (170 g)***Natural Enzymes Fiber (80% Chitin) Iron Kojic Acid
Code InfoItem # 26211, Sell by 041613
ClassificationClass III
Reason for RecallShiitake-Ya Gourmet Shiitake slices are being recalled because FDA test analysis showed presence of pesticide and polycyclic aromatic hydrocarbon residues: 0.208 ppm carbendazim, 0.072 ppm Fluoranthene and 0.092 ppm Pyrene. There are no tolerances for any of these pesticide residues.
Product Quantity27,648 jars
Recall NumberF-1634-2012

Class III Drugs Event

Event ID62053
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira, Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMagnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
Code InfoLot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
ClassificationClass III
Reason for RecallSuperpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Product Quantity164,568 containers
Recall NumberD-1390-2012

Class III Food Event

Event ID62276
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWorld Finer Foods, Inc.
CityBloomfield
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionReese Colossal Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00576
Code InfoUPC 70670-00576; OYSO MY-7 1520; OYSO MY-7 1521; OYSO My-7 1617; OYSO MY-7 1618; OYSO MY-7 1620.
ClassificationClass III
Reason for RecallAccording to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus.
Product Quantity2350 cases
Recall NumberF-1450-2012
Product DescriptionReese Medium Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00600.
Code InfoUPC 70670-00600; OYSO MY-7 1523; OYSO MY-7 1521; OYSO My-7 1618; OYSO; OYSO MY-7 1621.
ClassificationClass III
Reason for RecallAccording to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus.
Product Quantity900 cases
Recall NumberF-1451-2012
Product DescriptionReese Petite Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea, UPC 70670-00575.
Code InfoUPC 70670-00575; OYSO SY-7 1524; OYSO SY-7 1521; OYSO SY-7 1617; OYSO SY-7 1621.
ClassificationClass III
Reason for RecallAccording to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus.
Product Quantity950 cases
Recall NumberF-1452-2012

Class III Food Event

Event ID62285
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCamerican International
CityParamus
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionSmoked Oysters In cottonseed oil sold under the following brand names: 1) Fredmeyer Smoked Oysters In cottonseed oil Net Wt 3.75 oz (106 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Ralph's Smoked Oysters In Cottonseed Oil Distributed by Inter-American Products Cincinnati, Ohio 45202 Product of Korea; 3) Kroger Smoked Oysters In cottonseed oil , Distributed by the Kroger Co., Cincinnati, OH 45202, Product of Korea
Code InfoAll lots and UPCs Best by date 2013
ClassificationClass III
Reason for RecallInspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus.
Product Quantity1) 4600 units; 2) 7112 units; 3) 63,884 units
Recall NumberF-1454-2012
Product DescriptionWhole Oysters in Water under the following brand names: 1) Ralph's Whole Oysters in Water, Net Wt. 8 OZ (226 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Kroger Whole Oysters in Water Net Wt. 8 OZ (226g) Distributed by the Kroger Co., Cincinnati, Ohio 45202
Code InfoAll lots and UPCs
ClassificationClass III
Reason for RecallInspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus.
Product Quantity1) 2709 units; 2) 17,715 units
Recall NumberF-1455-2012
Product DescriptionNorthern Catch Fancy Whole Oysters Net Wt. 8 OZ (227g) Distributed by the Aldi Inc., Batavia, IL 60510 Product of Korea
Code InfoOBYL MY7 0427, OBYL MY7 0503, OBYL MY7 0507, OBYL MY7 0512, OBYL MY7 0515, OBYL MY7 0518, OBYL MY7 0519, OBYL MY7 0521, OBYL MY7 0524, OBYL MY39 0505, OBYL MY39 0506, OBYL MY39 0511, OBYL MY39 0513, OBYL SY7 0422, OBYL SY7 0429, OBYL SY7 0521, OBYL SY7 0524, OBYL SY7 0525, OBYL SY39 0510, OBYL SY39 0512, OBYL TY7 0426, OBYL TY7 0427, OBYL TY7 0501, OBYL TY7 0521
ClassificationClass III
Reason for RecallInspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus.
Product Quantity95000 units
Recall NumberF-1456-2012

Class III Food Event

Event ID62312
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKing Seafoods Inc.
CityColumbus
StateNJ
CountryUS
Distribution PatternNorth Carolina, South Carolina and Tennessee
 

Associated Products

Product DescriptionGranadaisa whole Oysters, Net WT. 8 oz (225 grams); Packed For King Seafoods Inc. PO BOX 107, Mount Holly, NJ USA 08060 Product of Korea Farm Raised, UPC 719882002049.
Code Infono coding
ClassificationClass III
Reason for RecallThe US FDA has removed all Korean certified shippers of molluscan shellfish (oysters, clams, mussels and scallops) from the Interstate Shellfish Shippers List (ICSSL), following a comprehensive FDA evaluation that determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls spelled out under the National Shellfish Sanitation Program.
Product Quantity
Recall NumberF-1460-2012
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