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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Class I Food Event

Event ID66279
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGarre Farms
CityPortland
StateOR
CountryUS
Distribution PatternDistributed in California, Oregon, Washington
 

Associated Products

Product DescriptionGreen Leaf Lettuce is sold in bulk cases under "Garre Farms" or "Rossi Farms" brand. There are 24 heads of green leaf lettuce packed in each cardboard box. The Garre Farms brand is labeled in parts: "***OREGON'S OWN!***Fresh Produce***GARRE FARMS, LLC***PORTLAND, OR 97230***PRODUCE OF U.S.A***". The Rossi Farms brand is labeled as "***ROSSI FARMS***3701 N.E. 122nd AVE PORTLAND, OR 97230*** PRODUCE OF U.S.A.***".
Code InfoNONE. No best by dates, no expiration dates, no lot codes.
ClassificationClass I
Reason for RecallGarre Farms is recalling green leaf lettuce due to a potential contamination with Listeria monocytogenes.
Product Quantity498 cases/24 heads of lettuce per case
Recall NumberF-0080-2014

Class I Food Event

Event ID66354
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNatureMost of New England, Inc.
CityMiddletown
StateCT
CountryUS
Distribution PatternStrawberry Banana: GA.,MA.,CT.,AR.,NY.,NJ.,MD.,NH.,TX., CA., FL; Vanilla Almond: GA, NC.,MA.,CT.,AR.,NY.,RI.,NJ.,MN.,SC.,AZ.,OH.,MD.,IN.,NH.,TX. St. Thoms, USVI
 

Associated Products

Product DescriptionNatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE VANILLA / ALMOND Dietary Supplement NET WEIGHT 3 LBS. (1362g). Product Number: 9950
Code InfoLot Numbers: 9950/3491, 9950/3636, 9950/3766, 9950/4011, 9950/4374, 9950/5025, 9950/5559
ClassificationClass I
Reason for RecallUndeclared allergens, milk,almond and soy.
Product Quantity370 units
Recall NumberF-0078-2014
Product DescriptionNatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE STRAWBERRY / BANANA Dietary Supplement NET WEIGHT 3 LBS. (1362g).
Code InfoLot Numbers: 9954/3793, 9954/4043, 9954/4205, 9954/4861
ClassificationClass I
Reason for RecallUndeclared allergens, milk and soy.
Product Quantity211 units
Recall NumberF-0079-2014

Class I Food Event

Event ID66375
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorpac Foods, Inc.
CityStayton
StateOR
CountryUS
Distribution PatternProducts distributed in Illinois, Missouri, and Nebraska.
 

Associated Products

Product DescriptionFrozen Sliced Carrots, packaged in 2 lbs. bag, sold under Simplot Classic brand. The UPC is 0 71179 1846 3 1. The product is labeled in parts: "***SIMPLOT CLASSIC***Sliced Carrots***NET WT 32 OZ. (2 LBS)***INGREDIENTS: CARROTS***KEEP FROZEN UNTIL READY TO USE. IF THAWED. DO NOT REFREEZE***Preparation Instructions***DISTRIBUTED BY: JR SIMPLOT COMPANY***BOISE, IDAHO 83707***PRODUCT OF U.S.A***".
Code InfoBEST BY SEP 2015/ 5M3 13X2L4 HH:MM. Product has Best By SEPTEMBER 2015. The code 5M3 13X2L4 HH:MM meant the product was repacked into Poly Bags on September 13, 2013, 07:47 am to 14:32 pm at NORPAC Foods, Inc., Quincy Foods, LLC Plant 2, 222 Columbia Way, PO Box 127, Quincy, WA 98848.
ClassificationClass I
Reason for RecallGreen shelled soybeans (Edamame) are potentially mixed in with sliced carrots.
Product Quantity40 cases/ 12 packages/2 lbs.
Recall NumberF-0081-2014

Class II Biologics Event

Event ID36297
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Oct-04
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSouth Florida Blood Banks, Inc.
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info 9745660
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0083-14
Product DescriptionPlatelets
Code Info 9745660
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0084-14
Product DescriptionFresh Frozen Plasma
Code Info 9745660
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0085-14

Class II Biologics Event

Event ID46127
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Oct-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info007FJ94213; 007FQ43738
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity2
Recall NumberB-2537-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info007FK98535;007GQ24832;007FQ44104;007FE46653; 007FJ93898;007FJ94001;007FJ94015;007FQ43731; 007FK98533
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity9
Recall NumberB-2538-13

Class II Biologics Event

Event ID46559
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Oct-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info007GG17861(1);007GG17861(2).
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity2 Units
Recall NumberB-2540-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info007FC32093; 007FJ93492; 07FQ43480; 07FQ43504; 007FY65994; 007FY66020;007FY66113;007FY66334; 007FY66339
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity9 units
Recall NumberB-2541-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info007FR30726
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity1
Recall NumberB-2542-13

Class II Biologics Event

Event ID60297
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Aug-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma Inc
CityWichita
StateKS
CountryUS
Distribution PatternSwitzerland, Germany, IL, MA, CA
 

Associated Products

Product DescriptionSource Plasma
Code Info41500410323; 41500406367; 41500361365; 41500358115; 41500693300; 41500388963; 41500312432; 41500297930; 41500284769; 41500280653; 41500379899; 41500376284; 41500240900; 41500236326; 41500232070; 41500213506; 41500201433; 41500156302; 41500143085; 41500139916; 41500127245; 41500151472; 41500107990; 41500097816; 41500095140; 41500190279; 41500178190; 41500289375; 41500260193; 41500304660; 41500252214; 41500396330; 41500373606; 41500230550; 41500221354; 41500213282; 41500204335; 41500146729; 41500115252; 41500109127; 41500101395; 41500196970; 41500196267; 41500110144; 41500089445; 41500082374; 41500080424; 41500191837
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity48 Units
Recall NumberB-2539-13

Class II Devices Event

Event ID64787
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare It
CityBarrington
StateIL
CountryUS
Distribution PatternUSA Nationwide Distribution in the state of OK
 

Associated Products

Product DescriptionCentricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.
Code InfoSoftware Version: 5.0
ClassificationClass II
Reason for RecallGE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Current, Prior or Baseline), with a border color, and with Study Date anotation. The newest study is labeled "Current", the next newest study is labeled "Prior", and if there are 3 or more studies open the oldest study is labeled "Baseline". When viewing multiple studies simultaneously, the border color and "Current"/"Prior"/"Baseline" labeling may be incorrect.
Product Quantity1 unit
Recall NumberZ-0034-2014

Class II Devices Event

Event ID65722
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSysmex America Inc
CityLincolnshire
StateIL
CountryUS
Distribution PatternWorldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.
 

Associated Products

Product DescriptionpocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
Code InfoProduct Code: 023-1861-8; Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098
ClassificationClass II
Reason for RecallThe data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Product Quantity193 units
Recall NumberZ-0100-2014

Class II Devices Event

Event ID65742
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntegra LifeSciences Corp.
CityPlainsboro
StateNJ
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
 

Associated Products

Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.
Code InfoK040235 Lot 160812
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity21 kits
Recall NumberZ-0054-2014
Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.
Code InfoK040235 Lot #020712;040912;050712;080612;110912;120912;140612;290812
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity62 kits (31 US; 31 non US)
Recall NumberZ-0055-2014
Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Code InfoK040235 Lot #020812l 050712; 070612; 090812; 140612;173419; 173438; 173515; 173538; 173540; 173720; 173725; 173887; 173918; 190712; 210612; 230812; 260712
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity503 kits(482 US; 21 non US)
Recall NumberZ-0056-2014
Product DescriptionInegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Code InfoK040244 Lot #190712; 240512;280612
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity109 kits
Recall NumberZ-0057-2014
Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Code InfoK002765 Lot # 130712, 210912, 220612, 172281, 172647, 172690, 173170, 173260, 173548, 173580, 173917, 173942
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity175 KITS
Recall NumberZ-0058-2014
Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Code InfoK002765 Lot # 090812, 170812
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity16 KITS
Recall NumberZ-0059-2014
Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Code InfoLot # 010612, 140512, 140612
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity42 Kits non US
Recall NumberZ-0060-2014
Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Code InfoLot # 030912, 110612, 170812, 230812
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity695 units (US and Foreign)
Recall NumberZ-0061-2014
Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Code InfoLot #170812
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity6 non US kits
Recall NumberZ-0062-2014
Product DescriptionIntegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Code InfoLot #060712, 170812
ClassificationClass II
Reason for RecallIntegra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Product Quantity34 non US kits
Recall NumberZ-0063-2014

Class II Biologics Event

Event ID65775
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNew York Blood Center, Inc.
CityLong Island City
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info W047013141970
ClassificationClass II
Reason for RecallBlood product, with an unacceptable pH, was distributed.
Product Quantity1
Recall NumberB-2430-13

Class II Biologics Event

Event ID65789
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBiomat USA, Inc.
CitySalt Lake City
StateUT
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0630289013;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.
Product Quantity1
Recall NumberB-2433-13

Class II Devices Event

Event ID65812
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc.
CityMountain View
StateCA
CountryUS
Distribution PatternWorldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey.
 

Associated Products

Product DescriptionAcuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
Code InfoModel# 10433816 Software Version 3.0 Serial#'s: 401239 401189 401214 400416 400599 400600 401254 401260 401259 401161 400836 401111 401290 400641 401116 401236 401245 401241 401255 401361 400141 401108 401109 401213 400675 400882
ClassificationClass II
Reason for RecallSoftware issue results in inaccurate 3D image may result in ablation in wrong location.
Product Quantity26 units
Recall NumberZ-0052-2014

Class II Biologics Event

Event ID65835
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Carolinas
CityCharlotte
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW227013030339;
ClassificationClass II
Reason for RecallBlood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.
Product Quantity1 Unit
Recall NumberB-2439-13

Class II Biologics Event

Event ID65858
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUpstate New York Transplant Services
CityBuffalo
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW280313700618 Part 1 ; W280313700618 Part 2;
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Product Quantity2
Recall NumberB-2443-13

Class II Biologics Event

Event ID65867
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionFresh Frozen Plasma (Apheresis)
Code InfoW036809423169;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2521-13
Product DescriptionRed Blood Cells(Apheresis)
Code InfoW036809423169;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2522-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW036809423169;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2523-13

Class II Devices Event

Event ID65897
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Spine, Inc.
CityRaynham
StateMA
CountryUS
Distribution PatternNationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.
 

Associated Products

Product DescriptionPIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Code Info287105005
ClassificationClass II
Reason for RecallDilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Product Quantity118 units
Recall NumberZ-2286-2013
Product DescriptionPIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Code Info287105010
ClassificationClass II
Reason for RecallDilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Product Quantity105 units
Recall NumberZ-2287-2013
Product DescriptionPIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Code Info287105014
ClassificationClass II
Reason for RecallDilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Product Quantity102 units
Recall NumberZ-2288-2013
Product DescriptionPIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Code Info287105018
ClassificationClass II
Reason for RecallDilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Product Quantity100 units
Recall NumberZ-2289-2013
Product DescriptionPIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Code Info287105090
ClassificationClass II
Reason for RecallDilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Product Quantity198 units
Recall NumberZ-2290-2013

Class II Food Event

Event ID65907
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEvershing International Trading Inc.
CitySan Jose
StateCA
CountryUS
Distribution PatternCA, WA, OR
 

Associated Products

Product DescriptionCoconut Tree Brand; Mut Gung Non; Ginger Candy; Ing: Ginger, Sugar, Water Sold in 8 oz sealed plastic pouches, and 12 oz sealed shrink wrapped plastic tubs. P. By: E.T.I. San Jose, CA
Code Info8 oz UPC: 000008000750 12 oz UPC: 000000991711
ClassificationClass II
Reason for RecallCalifornia Department of Public Health tested Ginger Candy and found that it may contain as much as .012 ppm of lead.
Product QuantityXX
Recall NumberF-0077-2014

Class II Biologics Event

Event ID65925
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasma Biological Services, Inc
CityNashville
StateTN
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code InfoNQ126229; NQ126044; NQ125644; NQ125453; NQ125068; NQ124769; NQ124420; NQ124111; NQ123788; NQ123524; NQ123203; NQ122916; NQ122657; NQ122282; NQ122128; NQ121618; NQ121429; NQ121047; NQ120771; NQ120365;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had been incarcerated, were distributed.
Product Quantity20
Recall NumberB-2447-13

Class II Biologics Event

Event ID65928
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmInterstate Blood Bank, Inc of Wisconsin
CityMadison
StateWI
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code InfoEQ106253; EQ105947; EQ105459; EQ105170; EQ104654; EQ124089; EQ123960; EQ123314; EQ122809; EQ122671; EQ122209; EQ122069; EQ121555; EQ121413; EQ120915; EQ120791; EQ120126; EQ119852; EQ119408; EQ119135; EQ118703; EQ118393; EQ117915; EQ117613; EQ117124; EQ116884; EQ116419; EQ116185; EQ115852; EQ115647; EQ115360; EQ115201; EQ114725; EQ114465; EQ113950; EQ113660; EQ113179; EQ112872; EQ112372; EQ111782; EQ111478; EQ110987; EQ110222; EQ109101; EQ108674; EQ107866; EQ107498; EQ107057; EQ106737;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity49
Recall NumberB-2525-13

Class II Biologics Event

Event ID65931
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida; New York
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW036808175079; W036812434119;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2529-13
Product DescriptionRed Blood Cells
Code InfoW036808175079; W036812434119;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2530-13

Class II Biologics Event

Event ID65939
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBioLife Plasma Services, L.P.
CityCasper
StateWY
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info12SWYC8777;
ClassificationClass II
Reason for RecallBlood product, which was not quarantined subsequent to receiving post donation information, was distributed.
Product Quantity1
Recall NumberB-2531-13

Class II Devices Event

Event ID65952
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAesculap, Inc.
CityCenter Valley
StatePA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionUNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Code InfoRT040R, all lot numbers
ClassificationClass II
Reason for RecallChanges were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.
Product Quantity217
Recall NumberZ-0031-2014

Class II Biologics Event

Event ID65961
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jul-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMid-South Regional Blood Center
CityMemphis
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionPlatelets
Code InfoW227713402838;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2532-13

Class II Biologics Event

Event ID65962
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jul-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternMichigan
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW087913304839;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1
Recall NumberB-2533-13

Class II Devices Event

Event ID65969
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynergetics Inc
CityO Fallon
StateMO
CountryUS
Distribution PatternNationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.
 

Associated Products

Product DescriptionSynergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.
Code InfoLot number: M222240
ClassificationClass II
Reason for RecallOne lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.
Product Quantity48/6-cannula boxes
Recall NumberZ-0051-2014

Class II Biologics Event

Event ID65974
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIndiana Blood Center
CityIndianapolis
StateIN
CountryUS
Distribution PatternIndiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW040712114281;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who provided history that warranted a deferral, was distributed.
Product Quantity1
Recall NumberB-2534-13

Class II Devices Event

Event ID66105
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOPTI Medical Systems, Inc
CityRoswell
StateGA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.
 

Associated Products

Product DescriptionModel BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.
Code InfoLots 252810, 315815, 319810, 319815, 321817, 367812, 370812
ClassificationClass II
Reason for Recall OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.
Product Quantity361 boxes of 25 cassettes each
Recall NumberZ-0029-2014

Class II Devices Event

Event ID66121
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVarian Medical Systems, Inc.
CityCharlottesville
StateVA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) distribution in CA and in the country of India.
 

Associated Products

Product DescriptionVARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
Code InfoLots #6078184-1, #6078184-2, #6078184-4
ClassificationClass II
Reason for RecallThe recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
Product Quantity3 sets
Recall NumberZ-0065-2014

Class II Food Event

Event ID66175
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Sep-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmChobani Idaho
CityTwin Falls
StateID
CountryUS
Distribution Patterndistributed nationwide
 

Associated Products

Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01001-4; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01007-6; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01013-7; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain-Club Pack, UPC 8-94700-10184-2
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity46,611 (6 oz) cases; 2,207 (16 oz) cases; 68,708 (32 oz) cases
Recall NumberF-0012-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01031-1; 6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01037-3; 6/32 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01043-4
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity1,954 (6 oz) cases; (16 oz) unknown cases; (32 oz) unknown cases
Recall NumberF-0013-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01002-1; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01008-3; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01014-4; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended-4 Value Pack, UPC 8-18290-01279-1
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity52,020 (6 oz) cases; 1,608 (16 oz) cases; 25,899 (32 oz) cases
Recall NumberF-0014-2014
Product DescriptionThe Chobani Flip products come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Vanilla Golden Crunch-Flip, UPC 8-18290-01229-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity21,229 cases
Recall NumberF-0015-2014
Product Description6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Vanilla Chocolate Chunk Blended, UPC 8-94700-01045-8
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity5,496 cases
Recall NumberF-0016-2014
Product Description6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Vanilla Chocolate Chunk, UPC 8-94700-01048-9
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity6,783 cases
Recall NumberF-0017-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Honey Blended, UPC 8-94700-01003-8
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantityunknown cases
Recall NumberF-0018-2014
Product Description6/4/3.5 oz. Chobani Bite 2% Milkfat Greek Yogurt Honey With Ginger, UPC 8-18290-01213-5
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity2,484 cases
Recall NumberF-0019-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry Fruit on the Bottom, UPC 8-94700-01004-5; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry on the Bottom-6 Value Pack, UPC 8-94700-01040-3; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry on the Bottom-4 Value Pack, UPC 8-18290-01281-4
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity114,965 cases
Recall NumberF-0020-2014
Product Description6/32 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry Blended, UPC 8-94700-01026-7
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity15,076 cases
Recall NumberF-0021-2014
Product Description6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Strawberry, UPC 8-18290-01261-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity4,428 cases
Recall NumberF-0022-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Strawberry Banana Blended, UPC 8-94700-01032-8; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Strawberry Banana Blended, UPC 8-18290-01280-7
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity74,295 cases
Recall NumberF-0023-2014
Product Description8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Swirlin Strawberry Banana-Tubes, 8-18290-01207-4
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity8,687 cases
Recall NumberF-0024-2014
Product Description3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry & Peach Blended-8 Value Pack, UPC 8-18290-01287-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity13,992 cases
Recall NumberF-0025-2014
Product Description3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry & Blueberry Blended-8 Value Pack, UPC 8-18290-01288-3
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity22,375 cases
Recall NumberF-0026-2014
Product DescriptionChobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Jammin Strawberry-Tubes, UPC 8-18290-01204-3
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity43,415 cases
Recall NumberF-0027-2014
Product DescriptionChobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 6/36/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes Variety Pack, UPC 8-18290-01230-2 6/16/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes, UPC 8-18290-01225-8;
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity28,513 cases
Recall NumberF-0028-2014
Product DescriptionThe Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Strawberry Sunrise-Flip, UPC 8-18290-01226-5
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity39,289 cases
Recall NumberF-0029-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom, UPC 8-94700-01005-2; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom-6 Value Pack, UPC 8-94700-01041-0; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom-4 Value Pack, UPC 8-18290-01282-1
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity102,893 cases
Recall NumberF-0030-2014
Product DescriptionChobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Blueberry, UPC 8-18290-01262-3; Chobani Champions also comes in 3.5 oz plastic cups: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry-Tubes, UPC 8-18290-01205-0
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity3,954 (3.5 oz) cases; 33,038 (2.25 oz) cases
Recall NumberF-0031-2014
Product Description6/16 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Blended, UPC 8-94700-01055-7
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity2,448 cases
Recall NumberF-0032-2014
Product DescriptionThe Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Blueberry Power-Flip, UPC 8-18290-01247-0
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity33,957 cases
Recall NumberF-0033-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach Fruit on the Bottom, UPC 8-94700-01006-9; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach on the Bottom-6 Value Pack, UPC 8-94700-01030-4; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach on the Bottom-4 Value Pack, UPC 8-18290-01284-5
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity92,036 cases
Recall NumberF-0034-2014
Product Description6/16 oz. Chobani 0% Non-Fat Greek Yogurt Peach Blended, UPC 8-94700-01029-8
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity1,331 cases
Recall NumberF-0035-2014
Product DescriptionThe Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Peachy Pistachio-Flip, UPC 8-18290-01248-7
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity36,191 cases
Recall NumberF-0036-2014
Product Description15/6 oz. Chobani 0% Non-Fat Greek Yogurt, BB, Straw, Peach Fruit on the Bottom-15 Variety Pack, UPC 8-18290-01216-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity86,974 cases
Recall NumberF-0037-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Lemon Blended, UPC 8-94700-01009-0
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity26,631 cases
Recall NumberF-0038-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple Fruit on the Bottom, 8-94700-01010-6; 6/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple on the Bottom-6 Value Pack, 8-94700-01038-0; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple on the Bottom-4 Value Pack, 8-18290-01285-2
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity75,902 cases
Recall NumberF-0039-2014
Product Description6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple Blended, UPC 8-94700-01046-5
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity1,756 cases
Recall NumberF-0040-2014
Product Description6/4/3.5 oz. Chobani Bite 2% Milkfat Low-Fat Greek Yogurt Caramel w/ Pineapple Chunks-Bite, UPC 8-18290-01211-1
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity24,406 cases
Recall NumberF-0041-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Passion Fruit Fruit on the Bottom, UPC 8-94700-01011-3
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity22,751 cases
Recall NumberF-0042-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Raspberry Fruit on the Bottom, UPC 8-94700-01012-0
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity88,528 cases
Recall NumberF-0043-2014
Product Description6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Raspberry Blended-4 Value Pack, UPC 8-18290-01276-0
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity10,454 cases
Recall NumberF-0044-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Pomegranate Fruit on the Bottom, UPC 8-94700-01015-1
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity63,493 cases
Recall NumberF-0045-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry Fruit on the Bottom, UPC 8-94700-01016-8; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry on the Bottom-6 Value Pack, UPC 8-94700-01039-7; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry on the Bottom-4 Value Pack, UPC 8-18290-01283-8
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity109,540 cases
Recall NumberF-0046-2014
Product Description6/16 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry Blended, UPC 8-94700-01056-4
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity1,224 cases
Recall NumberF-0047-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Apple Cinnamon Fruit on the Bottom, UPC 8-94700-01017-5
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity24,225 cases
Recall NumberF-0048-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango Fruit on the Bottom, UPC 8-94700-01033-5
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity58,188 cases
Recall NumberF-0049-2014
Product Description6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango Blended, UPC 8-94700-01018-2
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity640 cases
Recall NumberF-0050-2014
Product Description3/8/3.5 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango & Pineapple Blended-8 Value Pack, UPC 8-18290-01290-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity5,009 cases
Recall NumberF-0051-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blood Orange Fruit on the Bottom, UPC 8-94700-01034-2
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity36,232 cases
Recall NumberF-0052-2014
Product Description6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Orange Vanilla, UPC 8-94700-01058-8
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity629 cases
Recall NumberF-0053-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Orange Vanilla Blended, UPC 8-18290-01274-6; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Orange Vanilla Blended-4 Value Pack, UPC 8-18290-01278-4
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity21,992 cases
Recall NumberF-0054-2014
Product Description6/4/3.5 oz. Chobani Bite 2% Milkfat Low-Fat Greek Yogurt Fig with Orange Zest, UPC 8-18290-01210-4
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity3,384 cases
Recall NumberF-0055-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Banana Fruit on the Bottom, UPC 8-94700-01044-1
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity21,432 cases
Recall NumberF-0056-2014
Product Description6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Banana Honey, UPC 8-94700-01052-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity1,680 cases
Recall NumberF-0057-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Pear Fruit on the Bottom, UPC 8-18290-01202-9
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity10,668 cases
Recall NumberF-0058-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Apricot Fruit on the Bottom, UPC 8-18290-01258-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity4,191 cases
Recall NumberF-0059-2014
Product Description12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blackberry Fruit on the Bottom, UPC 8-18290-01259-3; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Blackberry on the Bottom-4 Value Pack, UPC 8-18290-01286-9
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity9,079 cases
Recall NumberF-0060-2014
Product Description3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry & Blackberry Blended-8 Value Pack, UPC 8-18290-01289-0
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity4,287 cases
Recall NumberF-0061-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Key Lime Blended, UPC 8-18290-01271-5; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Key Lime Blended-4 Value Pack, UPC 8-18290-01275-3
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity56,578 cases
Recall NumberF-0062-2014
Product DescriptionThe Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Key Lime Crumble-Flip, UPC 8-18290-01227-2
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity149,023 cases
Recall NumberF-0063-2014
Product Description12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Coconut Blended, UPC 8-18290-01273-9 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Coconut Blended-4 Value pack, UPC 8-18290-01277-7
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity47,630 cases
Recall NumberF-0064-2014
Product Description6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Raspberry with Dark Chocolate Chips, UPC 8-18290-01208-1
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity72,476 cases
Recall NumberF-0065-2014
Product Description6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Coffee with Dark Chocolate Chips-Bite, UPC 8-18290-01209-8
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity43,916 cases
Recall NumberF-0066-2014
Product Description6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Mint with Dark Chocolate Chips-Bite, UPC 8-18290-01293-7
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity7,060 cases
Recall NumberF-0067-2014
Product Description6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Very Berry, UPC 8-94700-01049-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity28,828 cases
Recall NumberF-0068-2014
Product Description4/4/3.5 oz. Champions 2% Milkfat Low-Fat Greek Yogurt Banana Honey & Very Berry-16 Variety Pack, UPC 8-94700-10102-6
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity17,107 cases
Recall NumberF-0069-2014
Product DescriptionChobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Flyin Dragon Fruit-Tubes, UPC 8-18290-01265-4 Chobani Champions product also comes in 3.5 oz. plastic cups: 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Dragon Fruit, UPC 8-18290-01264-7;
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity2,433 (3.5 oz) cases; 7,335 (2.25 oz) cases
Recall NumberF-0070-2014
Product DescriptionChobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages. 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Chillin Cherry-Tubes, UPC 8-18290-01206-7
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity5,040 cases
Recall NumberF-0071-2014
Product DescriptionChobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages. 16/2.25 oz. Chobani Champions Tubes -1.5% Milkfat Low-Fat Greek Yogurt Chillin Cherry & Swirlin Strawberry Banana-Tubes Variety Pack, UPC 8-18290-01240-1
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani Champtions brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity1,245 cases
Recall NumberF-0072-2014
Product DescriptionThe Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Almond Coco Loco-Flip, UPC 8-18290-01228-9
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity121,992 cases
Recall NumberF-0073-2014
Product DescriptionThe Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Tropical Escape-Flip, UPC 8-18290-01249-4
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity25,833 cases
Recall NumberF-0074-2014
Product DescriptionThe Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Nutty for Nana-Flip, UPC 8-18290-01260-9
Code InfoSep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
ClassificationClass II
Reason for RecallGreek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
Product Quantity28,920 cases
Recall NumberF-0075-2014

Class II Biologics Event

Event ID66178
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross The
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW20061303009800C is the Unit
ClassificationClass II
Reason for RecallBlood product, manufactured from an overweight whole blood unit, was distributed.
Product Quantity1
Recall NumberB-0015-14

Class II Biologics Event

Event ID66181
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansa, Missouri
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045013900556; W045013904307; W045013900566; W045013904334; W045013905579; W045013900557; W045013900566; W045013904334; W045013900555; W045013904474; W045013904527; W045013905579;
ClassificationClass II
Reason for RecallBlood products, for which the quality control testing was incomplete, were distributed.
Product Quantity12
Recall NumberB-0018-14

Class II Biologics Event

Event ID66192
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmArc Blood Services, New England Region
CityDedham
StateMA
CountryUS
Distribution PatternNew Hampshire; New York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW200413816944P1; W200413816944P2;
ClassificationClass II
Reason for RecallBlood products, for which the quality control testing was incomplete, were distributed.
Product Quantity2
Recall NumberB-0019-14

Class II Biologics Event

Event ID66193
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals LLC
CityGallup
StateNM
CountryUS
Distribution PatternUnited Kingdom
 

Associated Products

Product DescriptionSource Plasma
Code InfoGA1515074; GA1515597; GA1517031; GA1517352; GA1518671; GA1519093;
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving information regarding a post donation information, were distributed.
Product Quantity6
Recall NumberB-0020-14

Class II Biologics Event

Event ID66194
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals Orlando LLC
CityJacksonville
StateFL
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionSource Plasma
Code InfoJV0116772; JV0117212; JV0118666; JV0119251; JV0119886;
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Product Quantity5
Recall NumberB-0021-14

Class II Food Event

Event ID66221
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVinco Inc.
CityEvans City
StatePA
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionVinco's OsteoSheath Enhanced Bone Support, Calcium Supplement, 90 Tablets, distributed by Vinco, Inc., Evans City, PA;
Code InfoOsteoshealth UPC 739930205048, lot numbers 11080772 through 11080775, 12040763 through 12040767, 120101069 through 12101073 with expiration dates 10/13 to 2/15.
ClassificationClass II
Reason for RecallThe soy ingredient used to manufacture certain lots of Vinco's Osteosheath was potentially contaminated with Salmonella.
Product Quantity
Recall NumberF-0006-2014
Product Description Vinco's OsteoSheath 4 Enhanced Bone Support, Calcium Supplement, 120 Tablets, distributed by Vinco, Inc., Evans City, PA
Code InfoOsteosheath 4 UPC 739930275195, lot numbers 11060198 through 1106199, 11100897through 1110898, 1204780 through 1204781, 120101089 through 120101090, 13020640 through 13020641 with expiration dates 10/13 to 2/15.
ClassificationClass II
Reason for RecallThe soy ingredient used to manufacture certain lots of Vinco's Osteosheath 4 was potentially contaminated with Salmonella.
Product Quantity
Recall NumberF-0007-2014
Product DescriptionVinco's Fem-Vite Women's Anti-Oxidant Formula, Dietary Supplement, 60 Tablets, distributed by Vinco, Inc., Evans City, PA
Code InfoFem-Vite UPC 739930205086, lot numbers 11080560, 11080562, 12100217, 12100218 with expiration dates 10/13 to 2/15.
ClassificationClass II
Reason for RecallThe soy ingredient used to manufacture certain lots of Vinco's Fem-Vite was potentially contaminated with Salmonella.
Product Quantity
Recall NumberF-0008-2014

Class II Food Event

Event ID66227
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmThe Dannon Company, Inc.
CityTarrytown
StateNY
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionDANNON OIKOS Fruit on the Bottom GREEK NONFAT YOGURT BLUEBERRY 0% FAT
Code InfoExpiration codes: 24 SEP 2013 PS and 25 SEP 2013 PS
ClassificationClass II
Reason for RecallOIKOS Nonfat Yogurt Blueberry Flavor Single Serve 5.3 oz cups were recalled because the lid correctly identifies the product but the cup is incorrectly labeled as blackberry flavor. Additionally, the product is blueberry flavored but the ingredient statement is for the blackberry flavor, which does not declare carmine, a potential allergen ingredient that is used in manufacturing the blueberry flavored product.
Product Quantity10,833 cases (12 cups per case)
Recall NumberF-0076-2014

Class II Devices Event

Event ID66248
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Orthopaedics, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternDistributed in Puerto Rico and US Virgin Islands.
 

Associated Products

Product DescriptionSmartSet® Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.
Code Info.Lot #s: 1866567 2492886 2844909 3106436 3299572 3434618 F049Z40 1890991 2521804 2866892 3115022 3310546 3466958 1927220 2585596 2888115 3134757 3339992 3475370 1933603 2589374 2889319 3166736 3347549 3483245 1985488 2589379 2981608 3175434 3362229 3498627 2047388 2610503 2991395 3205074 3378764 3528522 2064474 2610505 3011228 3223183 3380098 3572240 2332458 2641279 3042105 3236354 3403313 3572270 2354798 2803352 3062608 3249497 3412748 3590469 2374539 2839097 3078622 3249526 3416122 F024ZA40
ClassificationClass II
Reason for RecallThe SmartSet® GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet® GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potential risk. SmartSet® GMV Endurance Gentamicin Bone Cement has only been cleared by the U.S. FDA for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Product Quantity16,040 units
Recall NumberZ-0064-2014

Class II Devices Event

Event ID66304
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Medical Optics, Inc.
CityMilpitas
StateCA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
 

Associated Products

Product DescriptionSTAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Code InfoAll units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
ClassificationClass II
Reason for RecallThis corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Product Quantity834 units in total
Recall NumberZ-0046-2014
Product DescriptionSTAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Code InfoAll units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
ClassificationClass II
Reason for RecallThis corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Product Quantity834 units in total
Recall NumberZ-0047-2014
Product DescriptionSTAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Code InfoAll units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
ClassificationClass II
Reason for RecallThis corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Product Quantity834 units in total
Recall NumberZ-0048-2014
Product DescriptionSTAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Code InfoAll units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
ClassificationClass II
Reason for RecallThis corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Product Quantity834 units in total
Recall NumberZ-0049-2014

Class II Devices Event

Event ID66310
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Sep-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPerkin Elmer Health Sciences, Inc.
CityGreenville
StateSC
CountryUS
Distribution PatternUS distribution in OH
 

Associated Products

Product DescriptionPerkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Code InfoJob number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.
ClassificationClass II
Reason for RecallSome devices may be contaminated on the back side of the device with glue in the blood application area.
Product Quantity65,984 devices
Recall NumberZ-0030-2014

Class II Devices Event

Event ID66312
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.
 

Associated Products

Product DescriptionPhilips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Code InfoM/N: 781220, 781230, 781301, 78129 and 78127. Codes: AM128, 1510, 1518, BA318, AM120, ZA178, ZA196, ZA107, ZA133, ZA172, ZA158, BA149 and ZA208.
ClassificationClass II
Reason for RecallThere is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
Product QuantityTotal 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panorama 0.6T: 55 units)
Recall NumberZ-0033-2014

Class II Devices Event

Event ID66317
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionSTERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code InfoLot# 13F050, 13F051, 13F049
ClassificationClass II
Reason for RecallAdvanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
Product Quantity2,995 units
Recall NumberZ-0044-2014

Class II Devices Event

Event ID66325
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternUSA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI
 

Associated Products

Product DescriptionBBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
Code InfoLot Number/ Exp. Date 3070436 September 12, 2014 3042466 August 16, 2014 3053239 August 30, 2014 3053240 August 30, 2014 3061013 September 6, 2014 3061014 September 6, 2014 3070433 September 12, 2014 3070437 September 12 , 2014
ClassificationClass II
Reason for RecallAn in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
Product Quantity187,000 tubes
Recall NumberZ-0028-2014

Class II Devices Event

Event ID66328
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada
 

Associated Products

Product DescriptionSTERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code InfoLot A: 0009*ENG 0003*FG 0048*FG 0050*MRB 0237*YAMATO 0239*YAMATO 0097*FSRIP 0097*FG 315*TTL 316*TTL 317*TTL 318*TTL 314*FG 325*TTL 326*TTL 334*FG 335*FG 329*TTL 345*TTL 357*FG 359*FG 358*FG 344*TTL 351*FG 347*TTL 352*TTL 348*TTL 348*FG 360*TTL 361*TTL 364*FG 362*TTL 383*YAMATO 365*TTL 368*TTL 371*FG 369*TTL 370*TTL 374*TTL 378*TTL 379*TTL 397*TTL 376*TTL 398*TTL 400*TTL 401*TTL 402*TTL 386*TTL 403*TTL 404*TTL 406*TTL 405*TTL 399*TTL 419*TTL 388*TTL 420*TTL 421*TTL 0239*CD33 422*TTL 423*TTL 429*YAMATO 424*TTL 439*YAMATO 425*TTL 427*TTL 346*TTL 423*TTL 372*TTL 430*TTL 428*TTL 395*TTL 431*TTL 433*TTL 447*YAMATO 432*TTL 434*TTL 435*TTL 437*TTL 436*TTL 453*YAMATO 454*YAMATO 452*YAMATO 440*TTL 412*TTL 455*YAMATO 456*YAMATO 468*FG 460*FG 458*FG 459*FG 462*FG 463*FG 464*FG 473*FG 470*FG 465*FG 488*YAMATO 476*FG 481*FG 487*YAMATO 502*FG 482*FG 501*FG 484*FG 485*FG 486*FG 483*FG 479*TTL 493*FG 492*FG 495*YAMATO 494*FG 509*YAMATO 504*TTL 503*TTL 505*TTL 506*TTL 507*TTL 512*TTL 524*TTL 540*YAMATO 538*YAMATO 539*YAMATO 537*YAMATO 541*YAMATO 508*TTL 520*TTL 519*TTL 518*TTL 516*TTL 521*TTL 522*TTL 523*TTL 556*TTL 525*TTL 526*TTL 524*TTL 528*TTL 529*TTL 530*TTL 532*TTL 531*TTL 515*FG 533*TTL 534*TTL 535*TTL 557*TTL 536*TTL 568*YAMATO 570*YAMATO 575*YAMATO 543*TTL 545*TTL 544*TTL 571*YAMATO 546*TTL 548*TTL 547*TTL 549*TTL 550*TTL 554*TTL 553*TTL 552*TTL 558*TTL 555*TTL 581*YAMATO 559*TTL 560*TTL 561*TTL 585*YAMATO 562*TTL 563*TTL 576*TTL 579*TTL 593*TTL 595*TTL 591*YAMATO 590*YAMATO 596*FG 597*TTL 606*YAMATO 602*TTL 601*TTL 599*TTL 598*TTL 607*YAMATO 604*TTL 603*TTL 612*FG 616*YAMATO 611*TTL 628*TTL 615*TTL 629*TTL 632*TTL 630*TTL 631*TTL 605*TTL 625*YAMATO 621*YAMATO 643*TTL 633*TTL 644*TTL 645*TTL 656*TTL 652*TTL 655*TTL 658*TTL 646*TTL 654*FG 659*FG 660*TTL 662*TTL 680*TTL 663*TTL 665*TTL 666*TTL 664*TTL 667*TTL 683*TTL 685*TTL 686*TTL 684*TTL 650*YAMATO 620*YAMATO 653*TTL 679*TTL 682*TTL 690*TTL 692*TTL 691*TTL 693*TTL 694*TTL 695*TTL 696*TTL 689*TTL 688*TTL 687*TTL 661*TTL 703*TTL 699*TTL 697*YAMATO 706*TTL 705*TTL 704*TTL 707*TTL 708*TTL 709*TTL 710*TTL 722*TTL 717*TTL 716*TTL 712*TTL 715*TTL 725*TTL 726*TTL 711*TTL 714*TTL 718*TTL 719*TTL 721*TTL 723*TTL 727*TTL 641*TTL 728*TTL 729*TTL 731*TTL 732*TTL 713*TTL 737*TTL 734*TTL 735*TTL 736*TTL 724*TTL 730*TTL 733*TTL 642*TTL 738*TTL 740*TTL 739*TTL 741*TTL 742*TTL 743*TTL 744*TTL 745*TTL 746*TTL 747*TTL 748*TTL 749*TTL 750*TTL 751*TTL 754*TTL 755*TTL 756*TTL 648*YAMATO 758*TTL 757*TTL 759*TTL 762*TTL 761*TTL 763*TTL 764*TTL 765*TTL 698*YAMATO 675*YAMATO 766*TTL 767*TTL 768*TTL 779*TTL 780*TTL 781*TTL 782*TTL 783*TTL 770*YAMATO 784*TTL 785*TTL 786*TTL 788*TTL 637*TTL 791*TTL 793*TTL 792*TTL 787*TTL 790*TTL 790*TTL 794*TTL 796*TTL 795*TTL 797*TTL 798*TTL 800*TTL 802*TTL 801*TTL 803*TTL 804*TTL 805*TTL 806*TTL 807*TTL 808*TTL 809*TTL 810*TTL 811*FG 813*TTL 814*TTL 815*TTL 673*YAMATO 816*TTL 817*TTL 818*TTL 819*TTL 884*YAMATO 822*TTL 824*TTL 821*TTL 820*FG 823*TTL 825*TTL 826*TTL 883*TTL 828*TTL 829*TTL 812*TTL 832*TTL 830*TTL 831*TTL 839*TTL 833*TTL 841*TTL 840*TTL 846*TTL 847*TTL 845*TTL 844*TTL 842*TTL 827*TTL 811*TTL 848*TTL 849*TTL 850*TTL 875*YAMATO 870*YAMATO 856*TTL 855*TTL 853*TTL 852*TTL 851*TTL 858*TTL 863*TTL 862*TTL 861*TTL 859*TTL 864*TTL 860*TTL 865*TTL 867*TTL 866*TTL 890*TTL 868*TTL 903*TTL 901*TTL 899*TTL 891*TTL 897*TTL 890*TTL 896*TTL 892*TTL 893*TTL 894*TTL 885*TTL 889*TTL 904*TTL 905*TTL 902*TTL 908*TTL 907*TTL 909*TTL 906*TTL 910*TTL 912*TTL 911*TTL 914*TTL 913*TTL 915*TTL 916*TTL 918*TTL 917*TTL 920*TTL 919*TTL 877*YAMATO 922*TTL 835*YAMATO 923*TTL 927*TTL 926*TTL 925*TTL 924*TTL 928*TTL 931*TTL 932*TTL 838*YAMATO 934*TTL 967*FG 935*TTL 936*TTL 938*TTL 939*TTL 945*TTL 947*TTL 940*TTL 946*TTL 950*TTL 973*TTL 950*TTL 976*TTL 951*TTL 974*TTL 984*TTL 949*FG 953*TTL 978*TTL 982*TTL 986*TTL 994*TTL 995*TTL 996*TTL 954*TTL 955*TTL 956*TTL 957*TTL 0201080042* 0201080027* 0201080041* 958* 959* 960* 961* 962* 975* 972* 971* 977* 985* 0201080051* 0201080052* 0201080045* 0201080055* 0201080053* 0201080054* 0201080044* 0201080057* 0201080046* 0201080061* 0201080063* 0201080062* 0201080031* 0201080039* 0201080040* 0201080035* 0201080065* 0201080064* 0201080074* 0201080072* 0201080073* 0201080069* 0201080070* 0201080066* 0201080048* 0202100004* 0201080075* 0201080077* 0201080076* 330*YAMATO 0137*FG 0136*FG 333*YAMATO 0139*FG 0097*FSRIP 194*FG 0130*FG 0135*FG 0260*YAMATO 0261*YAMATO 0201100001* 0058*FG 0064*FG 514*YAMATO 0202100030* 0202100032* 0202100033* 0202100034* 0202100035* 0202100036* 0202100037* 0202100045* 0141*FG 0195*FGYAMATO 0192*FGYAMATO 331*YAMATO 332*YAMATO 394*TTL 0202090032* 0202090036* 0202090038* 0202090039* 0202090040* 0202080018* 0202090001* 0232*YAMATO 0262*YAMATO 0070*FG 0071*FG 879*YAMATO 0193*FGYAMATO 753*YAMATO 752*YAMATO 0202100054* 0202100001* 0067*FG 0263*YAMATO 0199*FGYAMATO 0143*FG 0200*FGYAMATO 0072*FG 0066*FG 0201*FGYAMATO 887*YAMATO 887*YAMATO 0065*FG 0068*FG 0067*FG 0069*FG 0070*FG 0071*FG 0072*FG 0202*FGYAMATO 0202090003* 0202090008* 0202090034* 0202090007* 0265*YAMATO 0202090005* 0056*FG 0197*YAMATO 0207*YAMATO 0271*YAMATO 413*YAMATO 198*TTL 210*TTL 209*TTL 0265*FG 0266*YAMATO 264*YAMATO 204*TTL 203*TTL 0273*YAMATO 0272*YAMATO 0270*YAMATO 0212*YAMATO 0205*YAMATO 769*YAMATO 0202090010* 0211*YAMATO 0213*YAMATO 0202100002* 672*YAMATO 0216*YAMATO 0202100021* 0202100026* 0202100027* 0202100028* 0202100046* 0202100047* 0202100055* 0202100056* 336*TTL 0144*FG 441*YAMATO 339*TTL 0218*YAMATO 0217*YAMATO 0279*YAMATO 0275*YAMATO 340*TTL 0147*FG 343*FG 341*TTL 342*YAMATO 219*TTL 874*YAMATO 0155*FG 442*YAMATO 564*TTL 0223*YAMATO 0221*YAMATO 0220*YAMATO 0146*FG 565*TTL 0221*TTL 0201100002* 0202090012* 449*YAMATO 578*YAMATO 0076*FG 0145*FG 0156*FG 277*YAMATO 274*TTL 0224*YAMATO 0225*YAMATO 0222*YAMATO 276*YAMATO 0202090017* 0080*FG 0079*FG 353*TTL 0201080023* 775*YAMATO 0086*FG 0082*FG 0151*FG 0157*FG 0226*YAMATO 880*YAMATO 445*YAMATO 0202090024* 285*YAMATO 281*YAMATO 514*FG 0201080032* 0202090011* 582*FG 0202100020* 0202100040* 0202100041* 0202100053* 284*YAMATO 280*YAMATO 282*YAMATO 0246*YAMATO 0083*FG 0087*FG 356*TTL 446*YAMATO 584*YAMATO 944*YAMATO 0087*FG 777*YAMATO 771*YAMATO 514*FG 228*YAMATO 227*YAMATO 586*YAMATO 0202100007* 0201100003* 0201100004* 987*YAMATO 0202100006* 363*FG 0229*YAMATO 0233*YAMATO 286*YAMATO 291*YAMATO 0230*YAMATO 0234*YAMATO 0201080034* 588*YAMATO 0161*FGYAMATO 0236*YAMATO 0088*FG 0092*FG 0201080043* 367*YAMATO 0153*FGYAMATO 0158*FGYAMATO 0202100005* 0202100008* 610*YAMATO 701*TTL 0093*FG 0159*FGYAMATO 292*YAMATO 287*YAMATO 0240*YAMATO 0201090001* 98*FG 580*YAMATO 101*FG 0099*FG 472*YAMATO 471*YAMATO 375*YAMATO 0202090027* 290*YAMATO 0105*FG 0103*FG 0104*FG 0162*FGYAMATO 869*YAMATO 0165*FGYAMATO 0164*FGYAMATO 0163*FGYAMATO 0169*FGYAMATO 0166*FGYAMATO 380*YAMATO 0238*FG 0237*FG 293*YAMATO 295*YAMATO 773*YAMATO 0202090025* 106*FG 778*YAMATO 871*YAMATO 0175*FGYAMATO 382*YAMATO 375*FG 384*YAMATO 474*YAMATO 0201080067* 0241*YAMATO 294*YAMATO 296*YAMATO 298*YAMATO 634*YAMATO 0109*FG 0108*FG 381*YAMATO 385*YAMATO 389*YAMATO 0110*FG 0202100040* 0202100041* 0202100053* 0189*FGYAMATO 0170*FGYAMATO 303*YAMATO 300*YAMATO 0111*FG 987* 0202080006* 0202080008* 635*YAMATO 112*FG 0167*FGYAMATO 0184*FGYAMATO 0201070005* 0202080012* 0201080060* 0201080058* 0201080059* 0201070004* 0201080068* 305*YAMATO 302*YAMATO 390*YAMATO 872*YAMATO 0243*YAMATO 0107*FG 0202100003* 0202100009* 0202100011* 392*YAMATO 313*YAMATO 308*YAMATO 0202080010* 190*YAMATO 306*YAMATO 0113*FG 0115*FG 491*TTL 489*TTL 498*YAMATO 0116*FG 247*FG 500*YAMATO 0202100010* 0117*FG 0171*FGYAMATO 0118*FG 0202100015* 0202100016* 0202100012* 123*TTL 0202090026* 0172*FGYAMATO 408*YAMATO 0231*YAMATO 301*YAMATO 309*YAMATO 0201080002* 125*FG 122*FG 124*FG 396*F08A 414*YAMATO 407*YAMATO 415*YAMATO 410*YAMATO 0201070003* 0202080002* 0202080006* 181*FG 191*FG 320*YAMATO 321*YAMATO 0202100017* 0202100018* 0202100022* 0250*YAMATO 0201090002* 322*YAMATO 873*YAMATO 0127*FG 0253*YAMATO 0129*FG 513*YAMATO 668*YAMATO 0182*FGYAMATO 0176*FGYAMATO 834*YAMATO 324*YAMATO 327*YAMATO 0201080049* 0201080050* 0201080071* 0251*YAMATO 0256*YAMATO 128*FG 0179*FGYAMATO 0257*YAMATO 669*YAMATO 0202100058* 0202100059* 0202100057* 132*FG 636*YAMATO 0202090028* 0202100023* 0202080015* 0201070004* 00249*YAMATO 0202080001* 0185*FGYAMATO 0180*FGYAMATO 0121*FG 681*YAMATO 0202080020* 0202080021* 0202080022* 328*YAMATO 0201090003* 0202080019* 0202100019* 0202100024* 0202100025* 0202100029* 0202100031* 0186*FGYAMATO 0187*FGYAMATO 671*YAMATO 774*YAMATO 837*YAMATO 411*YAMATO 0244*TTL 0202080016* 438*YAMATO
ClassificationClass II
Reason for RecallAdvanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Product Quantity1,305 units total (654 units in US , 651 OUS )
Recall NumberZ-0043-2014

Class II Devices Event

Event ID66341
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
CityBeijing
State
CountryCN
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.
 

Associated Products

Product DescriptionGE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
Code InfoGE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015
ClassificationClass II
Reason for RecallGE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.
Product Quantity29
Recall NumberZ-0066-2014

Class II Devices Event

Event ID66361
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmConvergent Dental
CityNatick
StateMA
CountryUS
Distribution PatternUS distribution including states of: MA, CT, NY.
 

Associated Products

Product DescriptionSolea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Code InfoSerial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13
ClassificationClass II
Reason for RecallSpecific error condition could lead to unintended laser emission during laser activation.
Product Quantity5
Recall NumberZ-0050-2014

Class II Devices Event

Event ID66400
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMerit Medical Systems, Inc.
CitySouth Jordan
StateUT
CountryUS
Distribution PatternUS Distribution including the states of CO, VA, and MS.
 

Associated Products

Product DescriptionMerit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Code InfoPart Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388.
ClassificationClass II
Reason for Recall4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
Product Quantity200
Recall NumberZ-0045-2014

Class II Devices Event

Event ID66424
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling Firm AGFA Corp.
CityGreenville
StateSC
CountryUS
Distribution PatternWorldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
 

Associated Products

Product DescriptionIMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Code InfoN/A
ClassificationClass II
Reason for RecallSystem downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
Product Quantity4
Recall NumberZ-0035-2014

Class II Drugs Event

Event ID66462
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNephron Pharmaceuticals Corp.
CityOrlando
StateFL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25
Code InfoLots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Product Quantity689,568 cartons
Recall NumberD-66462-001

Class III Biologics Event

Event ID65796
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW333611036170; W039512040813;
ClassificationClass III
Reason for RecallBlood products, with outdated satellite bags attached, were distributed.
Product Quantity2
Recall NumberB-2434-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW333611112431; W333611072795; W333611048740; W333611032457; W333612096401;
ClassificationClass III
Reason for RecallBlood products, with outdated satellite bags attached, were distributed.
Product Quantity5
Recall NumberB-2435-13

Class III Biologics Event

Event ID65836
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmInnovative Blood Resources
CitySaint Paul
StateMN
CountryUS
Distribution PatternWisconsin
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW051513071676; W051513071671;
ClassificationClass III
Reason for RecallBlood products, which may have reached an unacceptable temperature during storage, were distributed.
Product Quantity2
Recall NumberB-2440-13

Class III Biologics Event

Event ID65859
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmAmerican National Red Cross
CityColumbus
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info16GQ57757;
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-2444-13

Class III Biologics Event

Event ID65927
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAurora Area Blood Bank Dba Heartland Blood Centers
CityAurora
StateIL
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW039713782345J;
ClassificationClass III
Reason for RecallBlood product, which did not have the preservative solution added but labeled with a 42 day expiration date, was distributed.
Product Quantity1
Recall NumberB-2524-13

Class III Biologics Event

Event ID65975
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmVirginia Blood Services
CityRichmond
StateVA
CountryUS
Distribution PatternPennsylvania; Virginia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW087613930893; W087613930899; W087613930895; W087613930891;
ClassificationClass III
Reason for RecallBlood products, labeled with an incorrect expiration date, were distributed.
Product Quantity4
Recall NumberB-2535-13
Product DescriptionFresh Frozen Plasma
Code InfoW087613930901;
ClassificationClass III
Reason for RecallBlood products, labeled with an incorrect expiration date, were distributed.
Product Quantity1
Recall NumberB-2536-13

Class III Biologics Event

Event ID66179
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTacoma Pierce County Blood Bank
CityTacoma
StateWA
CountryUS
Distribution PatternWashington; New Jersey; New York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW127813702227; W127813702232;
ClassificationClass III
Reason for RecallBlood products, collected using equipment for which quality control was not performed, were distributed.
Product Quantity2
Recall NumberB-0016-14
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW127813702233; W127813702234; W127813702236; W127813702215; W127813702216; W127813702217; W127813702219; W127813702223; W127813702224; W127813702225; W127813702226; W127813702228; W127813702231; W127813702209; W127813702211; W127813702202; W127813702203; W127813702204; W127813702205; W127813702206; W127813702207; W127813702208; W127813702242;
ClassificationClass III
Reason for RecallBlood products, collected using equipment for which quality control was not performed, were distributed.
Product Quantity23
Recall NumberB-0017-14

Class III Drugs Event

Event ID66207
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHi-Tech Pharmacal Co., Inc.
CityAmityville
StateNY
CountryUS
Distribution PatternPuerto Rico
 

Associated Products

Product DescriptionGILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716
Code Info1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014).
ClassificationClass III
Reason for RecallSubpotent; phenylephrine HCl
Product Quantity 50,848 bottles (total for 3 lots)
Recall NumberD-66207-001

Class III Devices Event

Event ID66293
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBio-Rad Laboratories
CityRedmond
StateWA
CountryUS
Distribution PatternUS Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
 

Associated Products

Product DescriptionFSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Code InfoLot 122822
ClassificationClass III
Reason for RecallThe FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.
Product Quantity23 kits
Recall NumberZ-0032-2014

Class III Food Event

Event ID66321
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Sep-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDean Foods, Inc.
CityDallas
StateTX
CountryUS
Distribution PatternProducts sold to various accounts in Southern California and Arizona only.
 

Associated Products

Product DescriptionFruit Rush Black Cherry Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
Code InfoAll production dates from May 21 to September 16, 2013, UPC: 0-41900-07369-5. Recall includes "Best By" dates through January 10, 2014.
ClassificationClass III
Reason for RecallThe product has the potential to spoil prematurely.
Product QuantityUnknown
Recall NumberF-0009-2014
Product DescriptionFruit Rush Fruit Punch Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
Code InfoAll production dates from May 21 to September 16, 2013, UPC: 0-41900-07362-6. Recall includes "Best By" dates through January 10, 2014.
ClassificationClass III
Reason for RecallThe product has the potential to spoil prematurely.
Product QuantityUnknown
Recall NumberF-0010-2014
Product DescriptionFruit Rush Lemon Lime Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
Code InfoAll production dates from May 21 to September 16, 2013, UPC: 0-41900-07368-8. Recall includes "Best By" dates through January 10, 2014.
ClassificationClass III
Reason for RecallThe product has the potential to spoil prematurely.
Product QuantityUnknown
Recall NumberF-0011-2014

Class III Devices Event

Event ID66394
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Sep-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAlere San Diego, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and countries of: South Africa and Canada
 

Associated Products

Product DescriptionAlere Triage® TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage® Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage® TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage® TOX Drug Screen Control 1 or Alere Triage® TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage® TOX Drug Screen Controls are to be used with the Alere Triage® TOX Drug Screen tests and Alere Triage® Meters to assist the laboratory in monitoring test performance.
Code InfoPart Number 94413. Lot Number C2681A.
ClassificationClass III
Reason for RecallAlere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.
Product Quantity38
Recall NumberZ-0053-2014

Class III Drugs Event

Event ID66402
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTolmar, Inc.
CityFort Collins
StateCO
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionKetoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Code InfoLots: 6111A exp 8/14, 6191A exp 10/14, 5523A exp1/14, 5617A exp 2/14, 5619A exp2/14, 5660A exp 3/14, 5689A exp 3/14, 5690A exp 3/14, 6114A exp 9/14, 6115A exp 9/14,6118A exp 9/14, 6122A exp 9/14, 5307A exp 8/13, 5391A exp 10/13, 5393A exp 10/13, 5392A exp 10/13, 5394A exp 10/13, 5396A exp 11/13, 5430A exp 11/13, 5431A exp 11/13, 5432A exp 11/13, 5434A exp 11/13, 5578A exp 11/13, 5491A exp 11/13, 5492A exp 11/13, 5493A exp 12/13, 5494A exp 12/13, 5531A exp 1/14 5661A exp 3/14, 5490A exp 11/13, 5533A exp 2/14, 5495A exp 12/13, 5534A exp 2/14, 5535A exp 2/14, 5621A exp 2/14, 5728A exp 3/14, 6117A exp 9/14, 6113A exp 9/14, 5776A exp 4/14, 6112A exp 8/14, 6119A exp 9/14, 6192A exp 10/14,and 6123A exp 10/14
ClassificationClass III
Reason for RecallSubpotent
Product Quantity391,055 bottles
Recall NumberD-66402-001

Mixed Classification Biologics Event

Event ID49928
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternCA, AZ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info07GJ22668
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0042-14
Product DescriptionPlasma Frozen
Code Info07GJ22668
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0043-14

Mixed Classification Biologics Event

Event ID65776
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood / dba CBCF
CityLauderhill
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036810053195;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2431-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036810053195;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2432-13

Mixed Classification Biologics Event

Event ID65815
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jun-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTennessee; New York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW043209035415;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2436-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW043209035415;
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2437-13
Product DescriptionPlatelets
Code InfoW043209035415;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2438-13

Mixed Classification Biologics Event

Event ID65846
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jun-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Blood Services Inc.
CityFlowood
StateMS
CountryUS
Distribution PatternMississippi; Switzerland
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW069111133260;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2441-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW069111133260;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2442-13

Mixed Classification Biologics Event

Event ID65924
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood / dba CBCF
CityLauderhill
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036810224582;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2445-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036810224582;
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2446-13

Mixed Classification Biologics Event

Event ID65926
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812437523;
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2448-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036812437523;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2449-13

Mixed Classification Biologics Event

Event ID65929
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood, Inc.
CityLantana
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2640057;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2526-13
Product DescriptionCryoprecipitated AHF
Code Info2640057;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2527-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2640057;
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2528-13
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