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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Class I Food Event

Event ID65151
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDelhaize America (Hannaford Bros)
CitySouth Portland
StateME
CountryUS
Distribution PatternMaine, New Hampshire, Vermont, New York and Massachusetts.
 

Associated Products

Product DescriptionHannaford Gourmet Oatmeal Raisin Cookies (9 oz. package) UPC # 0004126872715
Code InfoSold at retail bakery through 5/6/13
ClassificationClass I
Reason for RecallCookies may contain undeclared tree nuts
Product Quantity2899- 9 oz cookies
Recall NumberF-1587-2013
Product DescriptionHanna ford Gourmet Cookie Platter (36 oz. package), Includes oatmeal raisin cookies UPC # 04126874662
Code InfoSold at retail bakery through 5/6/13
ClassificationClass I
Reason for RecallCookies may contain undeclared tree nuts
Product Quantity 154 platters (36 oz)
Recall NumberF-1588-2013

Class I Food Event

Event ID65363
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGeneral Mills, Inc
CityMinneapolis
StateMN
CountryUS
Distribution PatternThe recall involved 2 customers with 6 shipping locations. WV, SC, VA, GA, TN.
 

Associated Products

Product DescriptionGeneral Mills, Cinnamon Toast Crunch, 25% Less Sugar, Self-Serve Bowl, Net WT 1.0 oz ( 28g), Distributed by General Mills Sales, Minneapolis, MN 55440, Package UPC 00016000294448. Case: General Mills, BOWLPAK, Cinnamon Toast Crunch, Reduced Sugar, 96 - 1 oz (28g) containers, Distributed by General Mills Sales, Minneapolis, MN 55440, Case UPC 10016000294445.
Code InfoBetter if Used By: Case Date Code: 31AUG2013, 02SEP2013
ClassificationClass I
Reason for RecallGeneral Mills is recalling a small quantity of single-serve reduced-sugar Cinnamon Toast Crunch bowlpak sold in foodservice establishments. The company was notified by an ingredient supplier that it had recalled an ingredient due to the possible presence of salmonella.
Product Quantity168 cases ( 96 individual 1.0 oz bowlpacks)
Recall NumberF-1589-2013

Class I Food Event

Event ID65426
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmButterfly Bakery Inc.
CityClifton
StateNJ
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionButterfly Bakery Harvest Berry Muffins (four muffins per package) Net. Wt. 14.5 OZ (410 g) UPC 6 43482 60014 8 Manufactured by: Butterfly Bakery Inc.200 Clifton Boulevard, Clifton, NJ 07013 T: 973.815.1501 Packaged in a plastic clam shell.
Code InfoUPC 6 43482 60014 8
ClassificationClass I
Reason for RecallWhole grain harvest berry muffins may contain undeclared walnuts.
Product Quantity42 cases
Recall NumberF-1586-2013

Class II Biologics Event

Event ID39842
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternNB
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info09FP49574
ClassificationClass II
Reason for RecallBlood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 Unit
Recall NumberB-1646-13
Product DescriptionFresh Frozen Plasma (Apheresis)
Code Info09FP49574
ClassificationClass II
Reason for RecallBlood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 Unit
Recall NumberB-1647-13

Class II Biologics Event

Event ID40694
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Aug-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternFL; MO; NJ; AR; Austria
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6643888; 6643907; 6643885; 6643794; 6643796; 6643919 6643938; 6643936; 6643878; 6653781; 6643910; 6643915 6639466; 6653784; 6639424; 6639423; 6639449; 6634622; 6633512; 6639467; 6643284; 6634456; 6643307; 6629134; 6643778; 6643494; 6643646; 8913062; 6651719
ClassificationClass II
Reason for RecallBlood Collection/Sterility compromised.
Product Quantity29 Units
Recall NumberB-1531-13
Product DescriptionCryoprecipitated AHF
Code Info6634622; 6629134
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air, were distributed.
Product Quantity2 units
Recall NumberB-1532-13
Product DescriptionPlatelets
Code Info6633512; 6635965
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air, were distributed.
Product Quantity2 units
Recall NumberB-1533-13
Product DescriptionFresh Frozen Plasma
Code Info6633512; 6634456; 6635965
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air, were distributed.
Product Quantity3 units
Recall NumberB-1534-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6654187; 6639454; 6644279; 6639388; 6639448; 6635965; 6643694; 6643690
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air, were distributed.
Product Quantity8 units
Recall NumberB-1535-13

Class II Biologics Event

Event ID41029
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Sep-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternNE,CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09GX44561
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Product Quantity1 Unit
Recall NumberB-1283-13

Class II Biologics Event

Event ID41440
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternPA, NJ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09FQ23731
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malaria endemic area, was distributed.
Product Quantity1 Unit
Recall NumberB-1284-13

Class II Biologics Event

Event ID42908
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Sep-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternNE; MA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09FF59678; 09FV14394; 09FV19303; 09FF56660
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity4 Units
Recall NumberB-1282-13

Class II Biologics Event

Event ID43942
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Dec-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida Georgia Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFL and SC
 

Associated Products

Product DescriptionRed Blood Cells
Code Info1953428; 4823063
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1539-13
Product DescriptionPlatelets
Code Info4823063
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-1540-13

Class II Biologics Event

Event ID44541
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Feb-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center University of Cincinnati Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info1623622
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-1526-13

Class II Biologics Event

Event ID44983
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternAL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info 4738509
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity1 unit
Recall NumberB-1538-13

Class II Biologics Event

Event ID45629
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmThe Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6452907
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-1287-13

Class II Biologics Event

Event ID46057
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLane Memorial Blood Bank
CityEugene
StateOR
CountryUS
Distribution PatternTN
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info7137125
ClassificationClass II
Reason for RecallBlood product, which were collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1291-13

Class II Biologics Event

Event ID46484
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHoxworth Blood Center University of Cincinnati Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2904512
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Product Quantity1 unit
Recall NumberB-1527-13
Product DescriptionPlatelets
Code Info2904512
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Product Quantity1 unit
Recall NumberB-1528-13

Class II Biologics Event

Event ID47561
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Feb-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmThe Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info5818588
ClassificationClass II
Reason for RecallBlood products, recovered from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1658-13
Product DescriptionFresh Frozen Plasma
Code Info5818588
ClassificationClass II
Reason for RecallBlood products, recovered from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1659-13

Class II Biologics Event

Event ID47926
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFL, AL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info5220672
ClassificationClass II
Reason for RecallBlood Products, in which Antibody Screen Testing was performed incorrectly, were distributed.
Product Quantity1 unit
Recall NumberB-1653-13
Product DescriptionRed Blood Cells
Code Info4668249
ClassificationClass II
Reason for RecallBlood Products, in which Antibody Screen Testing was performed incorrectly, were distributed.
Product Quantity1 unit
Recall NumberB-1654-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info4360813; 4360796
ClassificationClass II
Reason for RecallBlood Products, in which Antibody Screen Testing was performed incorrectly, were distributed.
Product Quantity2 units
Recall NumberB-1655-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info4668239A; 4668239B
ClassificationClass II
Reason for RecallBlood Products, in which Antibody Screen Testing was performed incorrectly, were distributed.
Product Quantity2 units
Recall NumberB-1656-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info4571232A; 4571232B; 4927022A; 4927022B; 4927021A; 4927021B.
ClassificationClass II
Reason for RecallBlood Products, in which Antibody Screen Testing was performed incorrectly, were distributed.
Product Quantity6 units
Recall NumberB-1657-13

Class II Biologics Event

Event ID48234
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Mar-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01KM49645
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1650-13
Product DescriptionPlasma Frozen
Code Info01KM49645
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1651-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info01KM49645
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1652-13

Class II Biologics Event

Event ID48271
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-07
Initial Firm Notification of Consignee or Public
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info9866577- Part 2
ClassificationClass II
Reason for RecallBlood product, labeled with incorrect expiration date and product code, was distributed.
Product Quantity1 unit
Recall NumberB-1288-13

Class II Biologics Event

Event ID48336
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFlorida Blood Services, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternAL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info4927543A
ClassificationClass II
Reason for RecallBlood product, possibly contaminated with air, was distributed.
Product Quantity1 unit
Recall NumberB-1289-13

Class II Biologics Event

Event ID48545
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternPA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info01FP60383
ClassificationClass II
Reason for RecallBlood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1290-13

Class II Biologics Event

Event ID49196
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW118808610534-part A; W118808610534-part B; W118808610531-part A; W118808610531-part B
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity4 units
Recall NumberB-1648-13

Class II Biologics Event

Event ID49827
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmThe Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFL, MO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW118808540372; 3629542
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of high risk behavior, was distributed.
Product Quantity2 units
Recall NumberB-1686-13
Product DescriptionFresh Frozen Plasma
Code InfoW118808540372; 3629542
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of high risk behavior, was distributed.
Product Quantity2 units
Recall NumberB-1687-13

Class II Biologics Event

Event ID50271
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Oct-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmThe Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW118808632579- part 1; W118808632579-part 2
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1541-13

Class II Biologics Event

Event ID55584
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Feb-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityGreat Falls
StateMT
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08GMTF0152, 08GMTF0785, 08GMTF3115, 08GMTF3717, 08GMTF4167, 08GMTF5308, 08GMTF5477, 08GMTF6333, 08GMTF7111, 08GMTF7230, 09GMTA0072, 09GMTA0203, 09GMTA1023, 09GMTA1171, 09GMTA2062, 09GMTA2185, 09GMTA3085, 09GMTA3242, 09GMTA4213, 09GMTA4385, 09GMTA5201, 09GMTA5577, 09GMTA6122, 09GMTA6475, 09GMTA6999, 09GMTA7336, 09GMTA7847, 09GMTA8158, 09GMTA8682, 09GMTA9013, 09GMTA9522, 09GMTA9881, 09GMTB0419, 09GMTB0761, 09GMTB1325, 09GMTB1856, 09GMTB2226, 09GMTB2766, 09GMTB3149, 09GMTB3666, 09GMTB4950, 09GMTB4800, 09GMTB5225, 09GMTB5675, 09GMTB6078, 09GMTB6638, 09GMTB7066, 09GMTB7641, 09GMTB8081, 09GMTB8908, 09GMTB9368, 09GMTB9998, 09GMTC0428, 09GMTC1053, 09GMTC1481, 09GMTC2610, 09GMTD1123, 09GMTD1517, 09GMTD2197, 09GMTD2583, 09GMTD3261, 09GMTD3745, 09GMTD4477, 09GMTD4893, 09GMTD5288, 09GMTD5796, 09GMTD6366, 09GMTD6843, 09GMTD7417, 09GMTD7821, 09GMTD8493, 09GMTD8887, 09GMTD9506, 09GMTD9908, 09GMTE0871, 09GMTE1679, 09GMTC2165.
ClassificationClass II
Reason for RecallBlood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity77 units
Recall NumberB-1529-13

Class II Food Event

Event ID59566
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmGood Source Incorporated
CityCarlsbad
StateCA
CountryUS
Distribution PatternIL, NE, RI, WY, CA, NV
 

Associated Products

Product DescriptionVegetarian Burger Mix, Item #VB 100, Pack size: 25lbs.
Code InfoLot#12173, 12305, 13065
ClassificationClass II
Reason for RecallGood Source Solutions is recalling Vegetarian Burger Mix because it may be contaminated with Salmonella. The recalled product contains Soy Protein Isolate that is on recall by CHS Inc. for Salmonella.
Product Quantity159 cases
Recall NumberF-1594-2013

Class II Biologics Event

Event ID62378
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmUnited States Blood Bank, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW223212445216
ClassificationClass II
Reason for RecallBlood product, labeled as leukoreduced but failed to meet QC levels for White Blood Cell counts, was distributed.
Product Quantity1 unit
Recall NumberB-1168-13

Class II Biologics Event

Event ID64026
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmSouth Texas Blood & Tissue Center
CitySan Antonio
StateTX
CountryUS
Distribution PatternFL; TX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW140912204923
ClassificationClass II
Reason for RecallBlood products, collected from a donor who may be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0980-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW140912204923
ClassificationClass II
Reason for RecallBlood products, collected from a donor who may be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0981-13

Class II Devices Event

Event ID64078
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMerit Medical Systems, Inc.
CityChester
StateVA
CountryUS
Distribution PatternGermany
 

Associated Products

Product DescriptionCustom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
Code InfoMerit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185
ClassificationClass II
Reason for RecallCustom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
Product Quantity134 trays
Recall NumberZ-1660-2013

Class II Biologics Event

Event ID64602
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHoxworth Blood Center UC Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW037712085626
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1507-13

Class II Biologics Event

Event ID64603
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems, Inc
CityAlbuquerque
StateNM
CountryUS
Distribution PatternNM
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW041212081657X
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-1510-13

Class II Drugs Event

Event ID64661
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmClinical Specialties Compounding Pharmacy
CityAugusta
StateGA
CountryUS
Distribution PatternFL, GA and SC.
 

Associated Products

Product DescriptionAcetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCAFBA:73, Exp date: 9/30/2013
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity300ml
Recall NumberD-632-2013
Product DescriptionAcetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCAJBA:76, Exp date: 10/4/2013
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-633-2013
Product DescriptionAcetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBDAC:98, Exp date: 8/12/2013
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity10ml
Recall NumberD-634-2013
Product DescriptionCataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDAEAC:07, Exp date: 5/5/2013; Lot number CABCCIBC:44, Exp date: 3/28/2013
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity80 ml total
Recall NumberD-635-2013
Product DescriptionCyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCBEBB:35, Exp date: 5/13/2013; Lot number CABACAB:76 Exp date: 7/1/2013; Lot number CABDAIAB:78, Exp date: 4/8/2013; Lot number CABDAEAC:80, Exp date: 5/5/2013 and Lot number CABDCCAC:31, Exp date: 5/23/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity55 ml
Recall NumberD-636-2013
Product DescriptionCyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCCIBC:89, Exp date: 3/28/2013; Lot number CABDBEAB:07, Exp date: 4/14/2013; Lot number CABDCIAB:42, Exp date: 4/28/2013 and Lot number CABDCCAC:37, Exp date: 5/23/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity87 ml total
Recall NumberD-637-2013
Product DescriptionDiazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBGAB:84, Exp date: 4/16/2013 and Lot number CABDAIAC:45, Exp date: 5/9/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity222 ml total
Recall NumberD-638-2013
Product DescriptionEstradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCACBA:20, Exp date: 3/31/2013; Lot number CABCABBB:22, Exp date: 4/30/2013; Lot number CABCBJBB:25, Exp date: 5/18/2013 and Lot number CABDAFAC:79, Exp date: 8/4/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity95 ml total
Recall NumberD-639-2013
Product DescriptionEstradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCADBA:96, Exp date: 4/1/2013 and Lot number CABCAIBA:31, Exp date: 4/6/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity17ml total
Recall NumberD-640-2013
Product DescriptionEstradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCBFBB:12, Exp date: 5/14/2013 and Lot number CABDAIAD:28, Exp date: 9/4/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity18ml total
Recall NumberD-641-2013
Product DescriptionGentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCAFBB:81, Exp date: 5/4/2013; Lot number CABCCEAJ:85 Exp date: 3/23/2013 and Lot number CABDCFAC:25 Exp date: 8/24/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity35ml total
Recall NumberD-642-2013
Product DescriptionHCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDAHAD:04 Exp date: 5/6/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity
Recall NumberD-643-2013
Product DescriptionHCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDAJAB:54, Exp date: 3/10/2013 and Lot number CABDABAC:38, Exp date: 5/31/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity
Recall NumberD-644-2013
Product DescriptionHCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBDAC:06, Exp date: 4/14/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity
Recall NumberD-645-2013
Product DescriptionHydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDAIAB:64, Exp date: 4/8/2013; Lot number CABDAEAB:21, Exp date: 4/4/2013; Lot number CABDBIAB:75, Exp date: 4/18/2013; Lot number CABDAEAC:00, Exp date: 5/5/2013 and Lot number CABDJAC:67, Exp date: 5/20/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity
Recall NumberD-646-2013
Product DescriptionInjection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCCHBB:59, Exp date: 5/26/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity
Recall NumberD-647-2013
Product DescriptionItraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDCBAC:71, Exp date: 3/23/2013 and Lot number CABDCGAC:35, Exp date: 3/28/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity10ml total
Recall NumberD-648-2013
Product DescriptionLaser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCCIBC:20, Exp date: 3/28/2013 and Lot number CABDAEAC:90, Exp date: 3/5/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity
Recall NumberD-649-2013
Product DescriptionLatanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDAFAD:09, Exp date: 5/4/2013
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity70ml total
Recall NumberD-650-2013
Product DescriptionMedroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDDBAB:21, Exp date: 7/30/2013; Lot number CABCBBBA:65, Exp date: 4/9/2013; Lot number CABCBBBA:77, Exp date: 4/9/2013; Lot number CABCBBBA:20 , Exp date: 4/9/2013; Lot number CABCCFBA:42, Exp date: 4/23/2013; Lot number CABCCFBA:59, Exp date: 4/23/2013; Lot number CABCCFBA:76, Exp date: 4/23/2013; Lot number CABCCFBA:85, Exp date: 4/23/2013; Lot number CABCCHBB:28, Exp date: 5/23/2013; Lot number CABCCHBB:46, Exp date: 5/23/2013; Lot number CABCCHBB:87, Exp date: 5/26/2013; Lot number CABCCHBB:30, Exp date: 5/26/2013; Lot number CABCBJBC:92, Exp date: 6/17/2013; Lot number CABCBJBC:93, Exp date: 6/17/2013; Lot number CABCBJBC:31, Exp date: 6/17/2013; Lot number CABDAIAC:21, Exp date: 8/7/2013; Lot number CABDDBAB:05, Exp date: 7/30/2013; Lot number CABDDBAB:03, Exp date: 7/30/2013; Lot numberCABDDBAB:43, Exp date: 7/30/2013; Lot number CABDAIAC:45, Exp date: 8/7/2013 and Lot number CABDAIAC:13, Exp date: 8/7/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity220ml total
Recall NumberD-651-2013
Product DescriptionMedroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDABAC:01, Exp date: 5/2/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity2ml total
Recall NumberD-652-2013
Product DescriptionMethionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDAHAB:35, Exp date: 4/7/2013 and Lot number CABDBIAC:77, Exp date: 5/19/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity255ml total
Recall NumberD-653-2013
Product DescriptionMethylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDCGAC:49, Exp date: 3/28/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity36ml
Recall NumberD-654-2013
Product DescriptionMethylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCBJBA:55, Exp date: 4/17/2013; Exp date: Lot number CABDCCAB:52, Exp date: 7/21/2013 and Lot number CABDCGAC:50, Exp date: 8/25/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity95ml total
Recall NumberD-655-2013
Product DescriptionMitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDAGAD:25, Exp date: 4/20/2013 and Lot number CABDAGAD:84, Exp date: 4/20/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity 50ml total
Recall NumberD-656-2013
Product DescriptionMitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDAGAD:68 , Exp date: 4/20/2013 and Lot number CABDAGAD:60, Exp date: 4/20/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity6ml total
Recall NumberD-657-2013
Product DescriptionOphthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBDAC:11, Exp date: 8/12/2013; Lot number CABCCHAJ:28, Exp date: 3/26/2013; Lot number CABCBBBA:57, Exp date: 4/9/2013; Lot number CABCCGBA:11, Exp date: 4/24/2013; Lot number CABCACBB:26, Exp date: 5/1/2013; Lot number CABCBGBB:54, Exp date: 5/15/2013; Lot number CABCCJBB:38, Exp date: 5/28/2013; Lot number CABCBDBC:40, Exp date: 6/11/2013; Lot number CABCCIBC:73, Exp date: 6/26/2013; Lot number CABDBBAB:32, Exp date: 7/10/2013; Lot number CABDCEAB:92, Exp date: 7/23/2013; Lot number CABDAHAC:76, Exp date: 8/6/2013; Lot number CABDCBAC:11, Exp date: 8/20/2013 and Lot number CABDAHAD:85, Exp date: 9/3/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity378ml total
Recall NumberD-658-2013
Product DescriptionOphthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBFAC:88, Exp date: 5/16/2013; and Lot number CABDCBAB:42, Exp date: 4/21/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity360ml total
Recall NumberD-659-2013
Product DescriptionPap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBFAC:52, Exp date: 5/16/2013; Lot number CABDBBAB:40, Exp date: 4/11/2013; Lot number CABDCAAC:15, Exp date: 5/21/2013; Lot number CABDCCAC:75, Exp date: 5/23/2013 and Lot number CABDAFAD:77, Exp date: 6/3/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity96ml total
Recall NumberD-660-2013
Product DescriptionPhenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBIAB:14, Exp date: 7/17/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity60ml
Recall NumberD-661-2013
Product DescriptionProgesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBFAC:48, Exp date: 5/17/2014; and Lot number CABDCEAB:14, Exp date: 4/25/2014.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity637ml total
Recall NumberD-662-2013
Product DescriptionSodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCCEAJ:09, Exp date: 3/23/2013; Lot number CABCBFBA:92, Exp date: 4/13/2013; Lot number CABDAGAC:58, Exp date: 8/5/2013 and Lot number CABDAEAD:01, Exp date: 8/31/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity116ml total
Recall NumberD-663-2013
Product DescriptionTest Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCAFBC:17, Exp date: 6/3/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity7ml
Recall NumberD-664-2013
Product DescriptionTest Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCBFBA:15, Exp date: 4/13/2013; Lot number CABCACBA:58, Exp date: 3/31/2013; Lot number CABCAHBB:54, Exp date: 5/6/2013; Lot number CABCCHBB:63, Exp date: 5/26/2013; Lot number CABCAFBC:31, Exp date: 6/3/2013; Lot number CABCCHBS:23, Exp date: 6/25/2013; Lot number CABDBAAB:64, Exp date: 7/9/2013; Lot number CABDAIAB:59, Exp date: 7/7/2013; Lot number CABDAFAC:48, Exp date: 8/4/2013; Lot number CABDBJAC:27, Exp date: 8/18/2013 and Lot number CABDABAD:61, Exp date: 8/28/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity219ml total
Recall NumberD-665-2013
Product DescriptionTest Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCBJBA:26, Exp date: 4/17/2013; Lot number CABCBEBB:55, Exp date: 5/13/2013; Lot number CABCBEBB:75, Exp date: 5/13/2013; Lot number CABCCBBC:96, Exp date: 6/19/2013; Lot number CABCCHBC:80, Exp date: 6/25/2013; Lot number CABDAJAB:88, Exp date: 7/8/2013; Lot number CABDAEAB:41, Exp date: 7/3/2013; Lot number CABDBBAB:23, Exp date: 7/10/2013; Lot number CABDBHAB:14, Exp date: 7/16/2013; Lot number CABDCEAB:13, Exp date: 7/23/2013; Lot number CABDCFAB:33, Exp date: 7/24/2013 and Lot number CABDABAD:38, Exp date: 8/28/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantityunknown
Recall NumberD-666-2013
Product DescriptionTest cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCBJBC:70, Exp date: 6/17/2013
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity7ml
Recall NumberD-667-2013
Product DescriptionTest cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDBHAB:54, Exp date: 7/16/2013
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity4ml
Recall NumberD-668-2013
Product DescriptionTest Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCCABB:74, Exp date: 5/19/2013 and Lot number CABCCABB:31 Exp date: 7/29/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity10ml total
Recall NumberD-669-2013
Product DescriptionTest cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCAFBC:67, Exp date: 6/3/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity12ml
Recall NumberD-670-2013
Product DescriptionTest Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCCHBB:03, Exp date: 5/26/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity 8ml
Recall NumberD-671-2013
Product DescriptionTest cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDCAAC:13, Exp date: 8/19/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity12ml
Recall NumberD-672-2013
Product DescriptionTest cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCCHBB:81, Exp date: 5/26/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity12ml
Recall NumberD-673-2013
Product DescriptionTest Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCACBB:31, Exp date: 10/28/2013 and Lot number CABDBGAB:74, Exp date: 1/11/2014.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity65ml total
Recall NumberD-674-2013
Product DescriptionTest Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCACBA:23, Exp date: 3/31/2013 and Lot number CABDAIAD:13, Exp date: 9/4/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity13ml
Recall NumberD-675-2013
Product DescriptionTest Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCACBA:16, Exp date: 10/2/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity3ml
Recall NumberD-676-2013
Product DescriptionTest Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCAIBA:36, Exp date: 4/6/2013; Lot number CABDDAAB:10, Exp date: 7/29/2013 and Lot number CABDAIAD:01 Exp date: 9/4/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity13ml total
Recall NumberD-677-2013
Product DescriptionTest cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABCAIBB:44, Exp date: 5/7/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity11ml
Recall NumberD-678-2013
Product DescriptionTetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDCCAB:46, Exp date: 4/22/2013; Lot number CABDAGAC:58, Exp date: 5/7/2013 and Lot number CABDAGAD:07 Exp date: 6/4/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity474ml total
Recall NumberD-679-2013
Product DescriptionVancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Code InfoLot number CABDCCAC:54, Exp date: 3/24/2013.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product Quantity20ml total
Recall NumberD-680-2013

Class II Biologics Event

Event ID64872
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Blood Connection, Inc.
CityPiedmont
StateSC
CountryUS
Distribution PatternTN; SC; NC; NY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW121613100889; W121612226398; W121612204049; W121612175707; W121612141358;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity5 units
Recall NumberB-1644-13

Class II Biologics Event

Event ID64880
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmInland Northwest Blood Center
CitySpokane
StateWA
CountryUS
Distribution PatternID
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW0685132003619
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications for release, was distributed.
Product Quantity1 unit
Recall NumberB-1645-13

Class II Biologics Event

Event ID64881
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Blood Connection, Inc.
CityPiedmont
StateSC
CountryUS
Distribution PatternSC
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW121612171658
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed
Product Quantity1 unit
Recall NumberB-1643-13

Class II Biologics Event

Event ID64882
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMedic Inc
CityKnoxville
StateTN
CountryUS
Distribution PatternTN
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW071213002861; W071212051756
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1642-13

Class II Devices Event

Event ID64888
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmClorox Healthcare Holdings, LLC (dba HealthLink)
CityJacksonville
StateFL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.
 

Associated Products

Product DescriptionHealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
Code Info1232041; 1232030, 1232028, 1232024, 1232021, 1232020, 1232015, 1232013, 1232010, 1232009, 1231324, 1231323, 1226436, 1226435 1226432, 1226421, 1226416, 1226415, 1226416, 1226417, 1226418, 1226419, 1222318, 1222319, 1222320, 1222321, 1222322, 1217409, 1217404, 1213926, 1213924, 1213923, 1213921, 1213918, 1213917, 1213916, 1213910, 1213907, 1213906, 1213905, 1213115, 1208740, 1208739, 1208738, 1208737, 1208736, 1208735, 1208734, 1208733, 1208732, 1208731, 1208730, 1208729, 1205343, 1205342, 1205341, 1205340, 1205339, 1205338, 1205337, 1205336, 1205335, 1205334, 1205333, 1205332, 1205331, 1205330, 1205329, 1203217, 1201930, 1201929, 1201928, 1201927, 1201926, 1134639, 1134638, 1134637, 1134636, 1129331, 1129330, 1129328, 1129327, 1129324, 1125634, 1125633, 1125632, 1125631, 1125630, 1125629, 1125628, 1125627, 1125626, 1125625, 1125624, 1125623, 1123522, 1123521, 1123520, 1123519, 1123517, 1123512, 1122926, 1122925, 1122924, 1122923, 1122922, 1122720, 1121521, 1119218, 1116715, 1116020, 1116019, 1113222, 1113221, 1113220, 1113219, 1113218, 1111812, 1111811, 1111810, 1111809, 1111808, 1111025, 1111024, 1111023, 1111022, 1110130, 1109622, 1109621, 1109620, 1109617, 1109020, 1109019, 1106224, 1106223, 1106222, 1106221, 1106220, 1106219, 1105421, 1105420, 1105419, 1105418, 1105417, 1105416, 1105415, 1104213, 1104212, 1104211, 1103825, 1103824, 1103320, 1103319, 1103318, 1103317, 1102611, 1102610, 1101218, 1035518, 1034723, 1034722, 1034721, 1034720, 1034719, 1030620, 1030619, 1030618, 1030617, 1030616, 1030615, 1028731, 1028730, 1028729, 1028728, 1028727, 1028726, 1028725, 1028724, 1028716, 1028717, 1028718, 1028719, 1028720, 1027217, 1027216, 1023916, 1023915, 1023911, 1023909, 1023906, 1023905, 1023113, 1023112, 1023109, 1023108, 1023107, 1023108, 1023109, 1019602, 1019603, 1019604, 1019611, 1019612, 1019613, 1019614, 1015220, 1015219, 1015218, 1013316, 1013220, 1013218, 1009814, 1001855, 1001853, 1001844, 1001840, 1001839, 1001838, 1001837, 1001836, 1001835, 1001834, 1001833, 1001832, 1001831, 1001830, 1001829, 1001828, 1001827, 1001826, 1001825, 1001824, 1001823, 1000524, 1000523, 1000522, 1000521, 1000520, 1000519, 1000517, 0935206, 0935205, 0935204, 0934417, 0934416, 0934415, 0931612, 0931010, 0931003, 0931002, 0931001, 0927925, 0927130, 0927129, 0926022, 0923119, 0923118, 0923117, 0923115, 0923016, 0921531, 0921530, 0921528, 0921527, 0919721, 0919717, 0919716, 0919710, 0917317, 0916226, 0916224, 0916222, 0916220, 0916218, 0913330, 0913329, 0913328, 0913327, 0911411, 0911409, 0911407, 0911406, 0911405, 0911404, 0911402, 0909921, 0909919, 0909917, 0909916, 0909915, 0909914, 0909912, 0907718, 0907620, 0907619, 0905817, 0905816, 0905811, 0905810, 0905809, 0905808, 0905806, 0905805, 0905803, 0905801, 0903521, 0903520, 0903519, 0903517, 0901334, 0901331, 0901330, 0901328, 0901326, 0901320, 0901317, 0834724, 0834722, 0834718, 0834322, 0834320, 0834319, 0834315, 0832613, 0832215, 0832214, 0831715, 0831018, 0829515, 0828716, 0828715, 0828416, 0826813, 0826613, 0825216, 0825215, 0823114, 0822809, 0822616, 0819321, 0819317, 0815814, 0811613, 0809412, 0807318, 0807317, 0807316, 0807313, 0807312, 0807114, 0807113, 0806515, 0806514, 0805921, 0805918, 0805719, 0805718, 0805717, 0804518, 0804517, 0802419, 0801917, 0801518.
ClassificationClass II
Reason for RecallDue to lack of sterilization.
Product Quantity1,044,600 units
Recall NumberZ-1654-2013
Product DescriptionPSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
Code Info1103316, 1100626, 1100625, 1100624, 1100623, 1100622, 1100621, 1100620, 1100619, 1100618, 1100617, 1100616, 1100615, 1100318, 1100317, 1100316, 1034725, 1034724, 1033414, 1031515, 1028733, 1028732, 1028723, 1028722, 1028721, 1028720, 1028719, 1028718, 1028717, 1028716, 1028715, 1028721, 1028722, 1028723, 1028706, 1028707, 1023914, 1023913, 1023912, 1023910, 1023908, 1023907, 1023904, 1023903, 1023902, 1023901, 1023114, 1023111, 1023110, 1023107, 1023106, 1023110, 1023111, 1023112, 1023113, 1023114, 1023115, 1023116, 1023117, 1023118, 1023119, 1023120, 1023121, 1023122, 1019605, 1019606, 1019607, 1019608, 1019609, 1019610, 1019615, 1019616, 1019617, 1019618, 1019619, 1015217, 1015216, 1015215, 1013315, 1013219, 1001861, 1001860, 1001859, 1001858, 1001857, 1001856, 1001854, 1001852, 1001851, 1001850, 1001849, 1001848, 1001847, 1001846, 1001845, 1001843, 1001842, 1001841, 1000527, 1000526, 1000525, 1000518, 0935203, 0935202, 0935201, 0934418, 0931016, 0931015, 0931013, 0931012, 0931011, 0931009, 0931008, 0931007, 0931006, 0931005, 0931004, 0930216, 0930215, 0930214, 0930213, 0927931, 0927930, 0927929, 0927928, 0927927, 0927926, 0927924, 0927923, 0927922, 0927921, 0927920, 0927919, 0927128, 0927127, 0927126, 0927125, 0927124, 0927123, 0927122, 0927121, 0927120, 0926021, 0926020, 0926019, 0926018, 0926017, 0926016, 0926015, 0923116, 0923019, 0923018, 0923017, 0922516, 0922515, 0921533, 0921532, 0921529, 0921526, 0921525, 0921524, 0921523, 0921523, 0921522, 0921517, 0919724, 0919723, 0919722, 0919720, 0919719, 0919718, 0919715, 0919714, 0919713, 0919712, 0919711, 0917612, 0917321, 0917320, 0917319, 0917318, 0917316, 0916228, 0916227, 0916225, 0916223, 0916221, 0916219, 0914718, 0914717, 0914716, 0914715, 0913326, 0913324, 0913323, 0913322, 0913321, 0911413, 0911412, 0911410, 0911408, 0911403, 0911401, 0909922, 0909920, 0909918, 0909913, 0907901, 0907819, 0907720, 0907719, 0907618, 0905824, 0905821, 0905820, 0905819, 0905818, 0905815, 0905814, 0905813, 0905812, 0905807, 0905804, 0905802, 0904319, 0903522, 0901335, 0901333, 0901332, 0901329, 0901327, 0901325, 0901324, 0901323, 0901322, 0901321, 0901319, 0901318, 0834723, 0834721, 0834720, 0834719, 0834321, 0834318, 0834317, 0834316, 0832616, 0832615, 0832614, 0832213, 0832212, 0831918, 0831917, 0831916, 0831915, 0831714, 0831713, 0831017, 0831016, 0831015, 0830415, 0829817, 0829816, 0829815, 0829514, 0829513, 0828717, 0826812, 0826612, 0826314, 0825214, 0823812, 0823811, 0823214, 0823115, 0822618, 0822617, 0819320, 0819319, 0819318, 0819316, 0819315, 0815815, 0815813, 0815812, 0815811, 0815810, 0811616, 0811615, 0811614, 0807319, 0807315, 0807314, 0807115, 0806513, 0805919, 0805917, 0805121, 0805119, 0804519, 0803518, 0802418, 0801517, 0800320, 0800319, 0800318, 0800317, 0736517, 0735515, 0735117, 0734818, 0734817, 0734417, 0734117, 0732517, 0732317, 0729217, 0728817.
ClassificationClass II
Reason for RecallDue to lack of sterilization.
Product Quantity1,032,700 units
Recall NumberZ-1655-2013
Product DescriptionARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
Code Info1232040, 1232039, 1232038, 1232037, 1232029, 1232027, 1232026, 1232025, 1232023, 1232022, 1232019, 1232018, 1232017, 1232016, 1232014, 1232012, 1232011, 1232008, 1232007, 1232006, 1231322, 1231321, 1231320, 1231315, 1226439, 1226438, 1226434, 1226433, 1226431, 1226430, 1226429, 1226428, 1226427, 1226426, 1226422, 1226420, 1226419, 1226418, 1226417, 1226415, 1226414, 1222301, 1222302, 1222303, 1222304, 1222305, 1222306, 1222307, 1222308, 1222309, 1222310, 1222311, 1222312, 1222313, 1222314, 1222315, 1222316, 1222317, 1222323, 1222324, 1222325, 1222326, 1222327, 1222328, 1222329, 1222330, 1222331, 1222332, 1222333, 1222334, 1222335, 1222336, 1222337, 1222338, 1222339, 1222001, 1217408, 1217407, 1217406, 1217405, 1217403, 1217402, 1217401, 1214505, 1213925, 1213922, 1213920, 1213919, 1213915, 1213914, 1213913, 1213912, 1213911, 1213909, 1213908, 1213904, 1213903, 1213902, 1213901, 1211614, 1211613, 1208728, 1208727, 1208726, 1208725, 1208724, 1208723, 1208722, 1208721, 1208720, 1207323, 1205328, 1205327, 1205326, 1205325, 1205324, 1205323, 1205322, 1205321, 1205320, 1205319, 1205318, 1205317, 1205316, 1205315, 1201925, 1201924, 1201923, 1201922, 1201921, 1201920, 1201919, 1201918, 1201917, 1201916, 1201915, 1201914, 1201913, 1201912, 1201911, 1201910, 1201909, 1200511, 1200319, 1134635, 1134634, 1134633, 1134632, 1134631, 1134630, 1134629, 1134628, 1134627, 1134626, 1134625, 1134624, 1129718, 1129329, 1129326, 1129325, 1129323, 1129322, 1129321, 1129320, 1129319, 1129318, 1129317, 1129316, 1129315, 1129314, 1128318, 1125622, 1125621, 1125620, 1125619, 1125618, 1125617, 1125616, 1125615, 1123516, 1123515, 1123514, 1123010, 1122921, 1122920, 1122919, 1122918, 1122917, 1122916, 1122915, 1122719, 1122718, 1122717, 1122716, 1121520, 1121519, 1121518, 1121517, 1121516, 1121515, 1120814, 1120727, 1120726, 1120725, 1120724, 1120723, 1120722, 1120721, 1120720, 1119923, 1119922, 1119921, 1119920, 1119919, 1119324, 1119323, 1119322, 1119321, 1119320, 1119319, 1118723, 1118722, 1118721, 1118720, 1118719, 1118718, 1118717, 1118716, 1118024, 1118023, 1118022, 1118021, 1118020, 1118019, 1118018, 1118017, 1118016, 1117410, 1117409, 1117408, 1117407, 1116714, 1116713, 1116712, 1116711, 1116710, 1116709, 1116418, 1116018, 1116017, 1116016, 1116015, 1116014, 1116013, 1113217, 1113216, 1112221, 1111807, 1111806, 1111805, 1111804, 1111518, 1111021, 1111020, 1111019, 1111018, 1111017, 1111016, 1110129, 1110128, 1110127, 1110126, 1110125, 1110124, 1110123, 1110122, 1109619, 1109618, 1109616, 1109018, 1109017, 1109016, 1109015, 1109014, 1108315, 1108314, 1108313, 1108312, 1108310, 1108309, 1108025, 1108024, 1108023, 1108022, 1108021, 1108020, 1106226, 1106225, 1105422, 1104210, 1104209, 1104208, 1104207, 1103919, 1102417, 1101819, 1101818, 1101817, 1101816, 1101815, 1100315, 1036135, 1036134, 1036133, 1036132, 1036131, 1036130, 1036129, 1036128, 1036126, 1036125, 1036124, 1036123, 1007711.
ClassificationClass II
Reason for RecallDue to lack of sterilization.
Product Quantity772,600 units
Recall NumberZ-1656-2013

Class II Biologics Event

Event ID64891
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPenrose-St Francis Health Services Blood Bank
CityColorado Springs
StateCO
CountryUS
Distribution PatternCO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW290613050045
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1641-13

Class II Biologics Event

Event ID64892
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPenrose-St Francis Health Services Blood Bank
CityColorado Springs
StateCO
CountryUS
Distribution PatternCO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW290613050044
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed
Product Quantity1 unit
Recall NumberB-1640-13

Class II Biologics Event

Event ID64893
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityDunwoody
StateGA
CountryUS
Distribution PatternGA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115113051972Y
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-1639-13

Class II Biologics Event

Event ID64895
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (the)
CityCharlotte
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionPlasma Frozen within 24 hours (FP24)
Code Info012KV39786
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving post donation information, were distributed.
Product Quantity1 unit
Recall NumberB-1637-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info012KV39786
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving post donation information, were distributed.
Product Quantity1 unit
Recall NumberB-1638-13

Class II Biologics Event

Event ID64906
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSouth Bend Medical Foundation, Inc.
CitySouth Bend
StateIN
CountryUS
Distribution PatternIN
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045212002293
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1633-13

Class II Devices Event

Event ID64973
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jun-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmThe Anspach Effort, Inc.
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
 

Associated Products

Product Description***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
Code InfoSC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation.
ClassificationClass II
Reason for RecallThe RPM of the Motor Handpiece may be less than 80,000 RPM.
Product Quantity61 units
Recall NumberZ-1657-2013
Product Description***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
Code InfoSC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
ClassificationClass II
Reason for RecallThe RPM of the Motor Handpiece may be less than 80,000 RPM.
Product Quantity61 units
Recall NumberZ-1658-2013
Product Description***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).
Code InfoSC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
ClassificationClass II
Reason for RecallThe RPM of the Motor Handpiece may be less than 80,000 RPM.
Product Quantity61 units
Recall NumberZ-1659-2013

Class II Devices Event

Event ID65022
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.
 

Associated Products

Product DescriptionGE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.
Code InfoSERIAL NUMBER 00000007C20103 0000010C2M0069 0000010C2M0181 0000010C2M0214 0000010C2M0259 0000010C2M0137 0000010C2M0159 0000010C2M0262 0000009C2M0084 0000010C2M0130 0000010C2M0218 0000010C2M0297 0000009C2M0108 0000010C2M0236 0000009C2M0167 0000010C2M0208 0000010C2M0295 0000000DUMMY01 00000009C20099 00000007C20141 00000595660BU2 0000010C2M0063 0000010C2M0083 0000009C2M0041 0000010C2M0180 0000010C2M0189 0000010C2M0174 00000593054BU0 00000007C20150 0000010C2M0027 0000010C2M0121 0000010C2M0229 0000010C2M0253 0000010C2M0122 0000010C2M0005 00000007C20173 0000009C2M0040 0000009C2M0077 0000010C2M0088 0000010C2M0097 0000010C2M0143 0000010C2M0192 0000010C2M0193 0000010C2M0204 0000010C2M0294 0000010C2M0269 0000010C2M0176 00000498682BU4
ClassificationClass II
Reason for RecallGE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.
Product Quantity48
Recall NumberZ-1616-2013

Class II Food Event

Event ID65057
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGreen Mountain Coffee Roasters
CityWaterbury
StateVT
CountryUS
Distribution PatternTX, LA, MD, IN, IL, NE, NC, MN, WI, FL, AL
 

Associated Products

Product DescriptionMaster Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs
Code InfoBest By: 15NOV2013 PL113 3049
ClassificationClass II
Reason for RecallRegular (caffeinated) Coffee individual K-cup packs were packaged inside multi unit retail boxes labeled Decaffeinated Coffee.
Product Quantity288,144 kcups/4,002 master cases (6 retail boxes per case)/ 24,012 retail boxes
Recall NumberF-1584-2013

Class II Devices Event

Event ID65139
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternUSA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
 

Associated Products

Product DescriptionComputed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code InfoThe following system code numbers and associated serial numbers are affected by this recall: System Code #728231, Serial #: 4001, 4003, 4016, 4020, 9009, 9029, 9030, 9033, 9034, 9037, 9038, 9040, 9041, 9043, 9044, 9045, 9048, 9049, 9051, 9052, 9054, 9056, 9058, 9059, 9062, 9063, 9064, 9065, 9066, 9067, 9068, 9069, 9070, 9071, 9072, 9073, 9074, 9075, 9077, 9080, 9081, 9083, 9086, 9087, 9088, 9089, 9092, 9093, 9094, 9096, 9098, 9099, 9104, 9105, 9106, 9107, 9108, 9112, 9118, 9120, 9126, 9127, 9131, 9135, 9137, 9138, 9140, 9142, 9143, 9148, 9151, 9156, 9159, 9160, 9162, 9163, 9166, 9171, 9172, 9173, 9175, 9177, 9180, 9187, 9190, 9195, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9213, 9214, 9215, 9216, 9217, 9218, 9235, 9243, 9259, 9501, 9502, 9503, 9504, 9505, 9506, 9507, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9516, 9517, 9518, 9519, 9520, 9521, 9522, 9523, 9524, 9525, 9526, 9527, 9528, 9529, 9530, 9531, 9532, 9533, 9534, 9535, 9536, 9537, 9538, 9539, 9540, 9541, 9542, 9543, 9545, 9546, 9547, 9548, 9549, 9550, 9551, 9552, 9553, 9554, 9555, 9556, 9557, 9558, 9559, 9560, 9561, 9562, 9563, 9564, 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9610, 9611, 9612, 9613, 9614, 9615, 9616, 9617, 9618, 9619, 9620, 9621, 9622, 9623, 9624, 9625, 9626, 9627, 9628, 9629, 9630, 9631, 9632, 9633, 9634, 9635, 9636, 9637, 9638, 9639, 9640, 9641, 9642, 9643, 9644, 9645, 9646, 9647, 9648, 9649, 9650, 9651, 9652, 9653, 9654, 9655, 9656, 9657, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9670, 9671, 9672, 9673, 9674, 9675, 9676, 9677, 9678, 9679, 9680, 9681, 9682, 9683, 9684, 9685, 9686, 9687, 9688, 9689, 9690, 9691, 9692, 9693, 9694, 9695, 9697, 9698, 9699, 9700, 9701, 9702, 9703, 9704, 9705, 9706, 9707, 9708, 9709, 9710, 9711, 9712, 9713, 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310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310023, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310058, 310059, 310060, 310061, 310062, 310063, 310065, 310066, 310067, 310068, 310069, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 333001, 333007 System Code #728323, Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079
ClassificationClass II
Reason for RecallPhilips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.
Product Quantity2348 total units: 2182 Brilliance CT 64 units; 95 Ingenuity Core units; and 71 Ingenuity Core128 units.
Recall NumberZ-1646-2013

Class II Devices Event

Event ID65159
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Cardiovascular Us Sales, Llc
CityWayne
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa.
 

Associated Products

Product DescriptionMAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment.
Code InfoYUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1
ClassificationClass II
Reason for RecallMAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0). Identification of the Extension device issue: By fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. When the lever is released, skin which might be within the gap could be pinched or cut.
Product Quantity13 Tables; 24 Extension devices
Recall NumberZ-1622-2013

Class II Devices Event

Event ID65166
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLinvatec Corp. dba ConMed Linvatec
CityLargo
StateFL
CountryUS
Distribution PatternUS Distribution including the states of FL, KY, LA, MI, NC, and NY.
 

Associated Products

Product DescriptionGENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
Code InfoProduct Number CFBC-4502, Lot #431437
ClassificationClass II
Reason for RecallIncorrect blue/white suture was used.
Product Quantity60 each of both units
Recall NumberZ-1619-2013

Class II Veterinary Event

Event ID65185
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWedgewood Village Pharmacy, Inc.
CitySwedesboro
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product Description1) Digoxin LS (0.05 mg/mL) Liver 50 mcg/mL Elixir, Oral for Veterinary Use Only Various Sizes, Packaged in 60 mL amber plastic bottle Store at room temperature Item Codes DIGOXI-SOL502VC and DIGOXISOL0005VC 2) Digoxin LS (0.15 mg/mL) Liver 150 mcg/mL Elixir, Oral for Veterinary Use Only Various Sizes, Packaged in 60 mL amber plastic bottle Store at room temperature Item Code: DIGOXI-SOL501VC
Code InfoDigoxin LS (0.05 mg/mL) Liver 50 mcg/mL: ITEM Code DIGOXI-SOL502VC and DIGOXISOL0005VC Lot 20121002@228, Beyond Use Date 03/31/2013 Lot 20121009@233, Beyond Use Date 04/07/2013 Lot 20121207@062, Beyond Use Date 06/07/2013 Lot 20130107@298, Beyond Use Date 07/06/2013 Lot 20130110@052, Beyond Use Date 07/06/2013 Lot 20130306@086, Beyond Use Date 09/02/2013 ITEM Code DIGOXI-SOL501VC Lot 20121101@195, Beyond Use Date 04/30/2013
ClassificationClass II
Reason for RecallDigoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.
Product Quantity
Recall NumberV-221-2013
Product DescriptionDigoxin LS (0.05 mg/mL) Chicken 50 mcg/mL Elixir, Oral for Veterinary Use Only Packaged in 60 mL amber plastic bottle Store at room temperature Item Code: DIGOXI-SOL003VC
Code InfoItem Code: DIGOXI-SOL0003VC Lot 20130108@042, Beyond Use date 07/07/2013 Lot 20130220@138, Beyond Use date 08/19/2013
ClassificationClass II
Reason for RecallDigoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.
Product Quantity
Recall NumberV-222-2013
Product DescriptionDigoxin (0.09 mg) Capsules, Oral for Veterinary Use Only 100 capsules Packaged in white plastic bottle Store at room temperature Item Code DIGOXI-CAP505VC
Code InfoLot 20121023@117, Beyond Use date 10/18/2013 Lot 20121106@197, Beyond Use date 11/01/2013
ClassificationClass II
Reason for RecallDigoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.
Product Quantity
Recall NumberV-223-2013
Product Descriptiona) Digoxin (Flavored) 0.015 mg/mL Suspension, Oral, for Veterinary Use Only 30 mL, Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS509VC b) Digoxin (Flavored) 0.002 mg/mL Suspension, Oral, for Veterinary Use Only 30 mL, Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS506VC c) Digoxin (Flavored) 0.075 mg/mL Suspension, Oral, for Veterinary Use Only, Various sizes, Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS502VC and DIGOXISUS0006VC d) Digoxin (Flavored) 0.1 mg/mL Suspension, Oral, for Veterinary Use Only, Various sizes, Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS503VC and DIGOXISUS0011VC e) Digoxin (Flavored) 0.125 mg/mL Suspension, Oral, for Veterinary Use Only, 60 mL , Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS508VC and DIGOXISUS0030VC
Code InfoItem Code DIGOXI-SUS509VC Lot 201211022@246, Beyond Use date 05/01/2013 Item Code DIGOXI-SUS506VC Lot 20121025@103 Beyond Use Date 04/23/2013 Item Code DIGOXI-SUS502VC and DIGOXISUS0006VC Lot 20121022@296, Beyond Use Date 04/20/2013 Lot 20121120@307, Beyond Use Date 02/17/2013 Lot 20121207@229, Beyond Use Date 06/05/2013 Item Code DIGOXI-SUS503VC and DIGOXISUS0011VC Lot 20121002@037, Beyond Use Date 03/31/2013 Lot 20121127@313, Beyond Use Date 05/26/2013 Lot 20130103@232, Beyond Use Date 07/02/2013 Lot 20130130@060, Beyond Use Date 07/29/2013 Lot 20130207@032, Beyond Use Date 08/06/2013 Lot 20130304@337, Beyond Use Date 08/31/2013 Lot 20130313@012, Beyond Use Date 09/09/2013 Item Code DIGOXI-SUS508VC and DIGOXISUS0030VC Lot 20121003@015, Beyond Use Date 04/01/2013 Lot 20130219@021, Beyond Use Date 08/18/2013
ClassificationClass II
Reason for RecallDigoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.
Product Quantity
Recall NumberV-224-2013

Class II Devices Event

Event ID65202
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBard Access Systems
CitySalt Lake City
StateUT
CountryUS
Distribution PatternNational and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
 

Associated Products

Product DescriptionStatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock® device provides stabilization for compatible medical tubes and catheters.
Code InfoLot JUWJF283
ClassificationClass II
Reason for RecallBARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the catheter.
Product Quantity3,875 units.
Recall NumberZ-1618-2013

Class II Devices Event

Event ID65205
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSurgical Instrument Service And Savings, Inc.
CityRedmond
StateOR
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product Description-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609 Surgical Knife
Code Info122279; 122493; 122504; 122609; 122669; 123190
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity56 units
Recall NumberZ-1623-2013
Product Description- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm. REF AR-4068-25TR Lot 122518 and Lot 123190. - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504. - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey). REF AR-4065S Lot 122590. -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263. Manual surgical instrument for general use
Code Info122504; 122518; 122504; 122590; 122592; 123190; 123263.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity15
Recall NumberZ-1624-2013
Product Description-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W. REF PXW35 Lot 122309 and Lot 123263. -Proximate Linear Cutter, w/o Staples 75mm. REF TLC75 Lot 122490 -Ethicon Proximate Plus MD, Skin Stapler Regular. REF PMR35 Lot 122753. -Proximate Plus, Rotating Head, Skin Stapler (White) Wide. REF PRW35 Lot 122406. - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular. REF PXR35 Lot 122675 and Lot 123263. -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. Ref. TX60B Lot 122490 Manual surgical instrument for general use
Code Info122300, 123263, 122490, 122753, 122406, 122675, 122309
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity13
Recall NumberZ-1625-2013
Product DescriptionGII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
Code Info123266
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity2
Recall NumberZ-1626-2013
Product Description-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
Code Info123263, 122279, 123190.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity6 units
Recall NumberZ-1627-2013
Product Description90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 -StarVac (Label/Packaging) -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 -StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595 -Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663 -Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765 -TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486 -TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283 -Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486 -VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466 -VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512 -VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455 -VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293, -VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318 -VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512 -VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356, -VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409 -VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639 -VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512 -Vulcan Saphyre II, 90 Degree Suction Probe, w/Integrated Cable, (Grey) 3.0mm. Ref. 7210111 Lot 122486 -Vulcan Saphyre II, 60 Degree, Bipolar Probe w/Suction, w/Integrated Cable, (Pewter) 3.0mm. Ref. 7210113 Lot 122734
Code Info122029, 122295, 122486, 122577, 122734, 122654, 123266, 122651, 122427, 122630, 122494, 122595, 122419, 122446, 122308, 122671, 122455, 122593, 122626, 122483, 123044, 122283, 122466, 122673, 122745, 122589, 122306, 122356, 122435, 122502, 122639, 122293, 122663, 122325, 122512, 122765, 122765, 122762, 122409, 122318.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity447 units
Recall NumberZ-1628-2013
Product Description- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
Code Info122295, 122308, 122455, 122875.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity10
Recall NumberZ-1629-2013
Product Description- Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless Steel 5.5mm x 12.0mm x 0.4mm Ref. 5023-160 Lot 123353 - Hall MicroChoice, Oscillating Saw Blade, Fine, Flat, Stainless Steel 5.5mm x 18.5mm x 0.4mm Ref. 5023-162 Lot 123353 - Hall MicroChoice, Sagittal Saw Blade, Fine 4.5mm x 25.5mm x 0.4mm Ref. 5023-139 Lot 122454 - Hall MicroChoice, Sagittal Saw Blade, Stainless Steel 9.5mm x 25.5mm x 0.4mm Ref. 5023-138 Lot 122454, 123353 - Large Sagittal Saw Blade 25mm x 89.5mm x 0.89mm Ref. 2108-102 Lot 122490 - Micro Choice Oscillating Saw Blade 5.5mm x 18.5mm x 0.40mm Ref. KM-3000 Lot 122440 - Micro Oscillating and Sagittal Saw Blade 9.0mm x 25mm x 0.51mm Ref. 2296-33-521 Lot 122609, 122429 - Oscillating and Sagittal Saw Blade 9.0mm x 31mm x 0.51mm Ref. 2296-33-225 Lot 122347 - Oscillating Sagittal Blade 9mm x 31mm x .38mm Ref. 2296-3-525 Lot 123263 - Oscillating Saw Blade 9.0mm x 25.0mm x .38mm Ref. SP-511 Lot 122631 - Oscillating Saw Blade 9mm x 25mm x .38mm Ref. 2296-3-511 Lot 122447 - Reciprocating Saw Blade, Double Sided Fixed Point Travel: 3.56mm 70mm x 12.5mm x 0.64mm Ref. 227-96-275 Lot 122490 - Round Fast Cutting Stainless Steel Bur, 8 Flute 4.8mm Ref. 1608-6-139 Lot 122447 - Sagittal Saw Blade 4.5mm x 25.4mm Ref. KM-3102 Lot 122465 - Small Oscillating Blade 9.0mm x 31.0mm x .4mm Ref. 2296-3-125 Lot 122447 - Small Oscillating Saw Blade 5.5mm x 11.5mm x 0.38mm Ref. 2296-3-410 Lot 122429 - Small Oscillating Saw Blade 5.5mm x 18.0mm x 0.4mm Ref. 2296-3-212 Lot 122511 - Small Oscillating Saw Blade 5.5mm x 18mm x 0.38mm Ref. 2296-3-412 Lot 122447 - Small Oscillating Saw Blade 7mm x 18.5mm x 0.38mm Ref. 2296-3-114 Lot 122429, 122511 - Small Oscillating Saw Blade 9.0mm x 31mm x 0.4mm Ref. 2296-3-225 Lot 122590, 122447 - Small Sagittal Saw Blade, Fine Tooth 9.5mm x 25.5mm x 0.4mm Ref. ZS-338 Lot 122647 - System 4 & System 2000 Sagittal Saw Blade 12.5mm x 81.5mm x 1.19mm Ref. 2108-152 Lot 122490 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 1.27mm x 11mm x 90mm Ref. 4111-127-090 Lot 123263 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 18mm x 75mm x 0.89mm Ref. 4118-089-075 Lot 123263 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 25mm x 90mm x 1.27mm Ref. 4125-127-090 Lot 122347 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual-Cut 18mm x 90mm x 1.35mm Ref. 4118-135-090 Lot 122347 Surgical instrument motors and accessories/attachments
Code Info122590, 123263, 122347, 122454, 122490, 122631, 122289, 123353, 122609, 122465, 122440, 122429, 122447, 122647, 122511.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity73
Recall NumberZ-1630-2013
Product Description- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322 - Drill Bit, Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289, 122322 - Egg Micro Bur, 10 Flute, Stainless Steel 4.0mm Ref. 1608-2-35 Lot 122429, 122347 - Hall Micro Bur, Oval, Long, 8-Flute, Carbide 4.0mm x 8.0mm Ref. 5092-136 Lot 123353 - Micro Bur, Round, Stainless Steel 3.2mm Ref. 1608-2-11 Lot 122447, 122347 - Oval Bur, Fast Cutting, 8-Flutes, Carbide, 44.5mm Total Length, 18.6mm Exposure 4.0mm x 7.9mm Ref. 227-10-62 Lot 122411 - Oval Bur, Solid, 8-Flute, Medium, Head Length: 7.7mm, Carbide 4.0mm x 48mm Ref. 5300-10-901 Lot 122647 - Oval Cutting Carbide Bur, Medium, (8-Flute) 4.0mm Ref. 5091-136 Lot 123353, 122454 - Round Bur, Medium, Solid 8-Flute, Carbide 4.0mm x 48.3mm Ref. 5300-10-511 Lot 122665 - Round Bur, Micro, 8-Flute, Exposure: 28.2mm Stainless Steel 2.4mm x 54mm Ref. 1608-2-9 Lot 122447 - Twist Drill, Quick Coupling 110mm 2.5mm Ref. 310.25 Lot 122289, 122322 - Wire Pass Drill Bit 1.5mm Ref. 1608-2-59 Lot 122511 Surgical instrument motors and accessories/attachments
Code Info122347, 122454, 122411, 122289, 123353, 122429, 122322, 122447, 122665, 122647, 122511.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity30
Recall NumberZ-1631-2013
Product DescriptionBarron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
Code Info122336
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity1
Recall NumberZ-1632-2013
Product DescriptionAbrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Ref. 7205326 Lot 122609 - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609 - CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631 arthoscope - CoolCut Bone Cutter (Blue/Orange) 4.0mm Ref. AR-8400BC Lot 122631 - CoolCut Bone Cutter (Blue/Orange) 5.5mm Ref. AR-8550BC Lot 122631 - CoolCut Dissector (Blue/Blue) 3.5mm Ref. AR-8350DS Lot 123190 - CoolCut Dissector (Blue/Blue) 4.0mm Ref. AR-8400DS Lot 123190, 122493, 122631 - CoolCut Dissector (Blue/Blue) 5.0mm Ref. AR-8500DS Lot 122493 - CoolCut Dissector Small Joint (Blue/Blue) 3.0mm Ref. AR-7300DS Lot 123190, 122493, 122631, - CoolCut Excalibur (Blue/Beige) 3.8mm Ref. AR-8380EX Lot 122631 - CoolCut Excalibur (Blue/Beige) 4.0mm Ref. AR-8400EX Lot 122631 - CoolCut Oval Burr (12 Flutes) (Blue/White) 5.5mm Ref. AR-8550OBT Lot 122631 - CoolCut Oval Burr (8 Flute) (Blue/White) 4.0mm Ref. AR-8400OBE Lot 122493, 122631, 122279 - CoolCut Oval Burr (8 Flute) (Blue/White) 5.0mm Ref. AR-8500OBE Lot 122493 - CoolCut Round Burr (8 Flute) (Blue/Red) 5.0mm Ref. AR-8500RBE Lot 123190 - CoolCut Sabre (Blue/Green) 3.8mm Ref. AR-8380SR Lot 122493 - DYONICS ELITE Achromobacter (Sage Green) 4.0mm Ref. 72200730 Lot 122665 - Elite* AcromioBlaster Burr (Brick Red/Yellow) 5.5mm Ref. 72200731 Lot 122665 - Formula Aggressive Plus Cutter (Beige/Blue) 5.5mm Ref. 375-564-000 Lot 122309 - Formula Aggressive Plus Cutter (Dk. Blue/Lt. Blue) 5.0mm Ref. 375-554-000 Lot 122490 - Formula Aggressive Plus Cutter (Yellow/Blue) 3.5mm Ref. 375-534-000 Lot 122518, 122309 - Formula Aggressive Plus Cutter Large Hub, (Red/Blue) 4.0mm Ref. 375-544-000 Lot 122594, 122588, 122518, 122278 - Formula Barrel Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-951-012 Lot 122278 - Formula Barrel Bur, 12-Flute (Blue/Blue) 5.0mm Ref. 375-951-112 Lot 122594 - Formula Barrel Bur, 12-Flute (Red/Red) 4.0mm Ref. 375-941-012 Lot 122594, 122518 - Formula Barrel Bur, 6-Flute (Beige/Beige) 5.5mm Ref. 375-951-000 Lot 122588 - Formula Barrel Bur, 6-Flute (Red/Red) 4.0mm Ref. 375-941-000 Lot 122588 - Formula Full Radius Cutter, Small Joint, (Grey) 2.5mm Ref. 375-627-000 Lot 122594 - Formula Hooded Abrasion Bur, Small Joint, (Orange) 3.0mm Ref. 375-647-000 Lot 122518 - Formula Resector Cutter (Red/Black) 4.0mm Ref. 375-542-000 Lot 122588 - Formula Resector Cutter (Yellow/Black) 3.5mm Ref. 375-532-000 Lot 122594, 122490, 122588 - Formula Round Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-950-012 Lot 122278 - Formula Round Bur, 12-Flute (Red/Red) 4.0mm Ref. 375-940-012 Lot 122594 - Formula Round Bur, 6-Flute (Blue/Blue) 5.0mm Ref. 375-950-100 Lot 122490 - Formula Round Bur, 6-Flute (Red/Red) 4.0mm Ref. 375-940-000 Lot 122518 - Formula Slotted Whisker (Red/Red) 4.0mm Ref. 375-548-000 Lot 122594 - Formula Tomcat Cutter (Red/White) 4.0mm Ref. 375-545-000 Lot 122588 - Formula Tomcat Cutter (Yellow/White) 3.5mm Ref. 375-535-000 Lot 122588 - Full Radius Blade (Yellow) 4.5mm Ref. 7205306 Lot 122347, 122454, 122609, 123270, 122665 - Full Radius Blade, (Beige) 3.5mm Ref. 7205305 Lot 122609, 122665 - Full Radius Blade, (Orange) 5.5mm Ref. 7205307 Lot 122665 - Full Radius ELITE Blade (Beige) 3.5mm Ref. 7210751 Lot 122465, 122665 - Full Radius Mini Blade, 7cm Length (Red) 2.9mm Ref. 3419 Lot 122609 - Full Radius Resector Large Hub, Sterling, Shaver, (Yellow) 4.2mm Ref. 9247A Lot 123263, 122592, 123353 - Full Radius Resector, Large Hub, Merlin, Pre-Bent 15 Degree, (Yellow/Black) 4.2mm Ref. C9241 Lot 123263 - Full Radius Resector, Sterling, Large Hub, (Yellow) 3.5mm Ref. C9248 Lot 123263, 122592, 122511 - Gator Blade, Large Hub, Sterling, Shaver (Orange) 3.5mm Ref. C9264 Lot 122592 - Gator Blade, Large Hub, Sterling, Shaver (Orange) 4.2mm Ref. 92563A Lot 123263 - Gator Blade, Micro Hub, Sterling 7.6cm, (Orange) 3.5mm Ref. C9962 Lot 123353 - Gator Blade, Micro Hub, Sterling, Shaver 7.6cm, (Orange) 2.9mm Ref. C9961 Lot 123263 - Gator Blade, Large Hub, Sterling, Working Length: 8.2cm, (Orange) 2.9mm Ref. C9961A Lot 122511 - Great White Blade, Sterling, Large Hub (White) 4.2mm Ref. 9299A Lot 123263, 122592, 122482, 123353 - Great White Blade, Sterling, Large Hub (White) 5.5mm Ref. 9599A Lot 123353, 122511 - Great White Blade, Large Hub, Merlin, Pre-Bent 15 Degree Max., (White/Black) 4.2mm Ref. C9299P Lot 123353 - Great White Blade, Large Hub, Sterling, Shaver, (White) 3.5mm Ref. 9399A Lot 123263, 122592, 123353 - HeliCut, Burr (Slate) 4.5mm Ref. 7205727 Lot 122609 - Incisor Blade (Lime Green) 4.5mm Ref. 7205313 Lot 122454 - Incisor Blade, (Medium Grey) 3.5mm Ref. 7205312 Lot 123270 - Incisor Plus Blade (Teal) 5.5mm Ref. 7205459 Lot 122609, 122465, 123270 - Incisor Plus Blade, (Violet) 4.5mm Ref. 7205345 Lot 122338, 122609, 122465, 123270, 122434, 122665 - INCISOR Plus ELITE (Slate) 4.5mm Ref. 7210976 Lot 122590 - INCISOR Plus ELITE (White) 3.5mm Ref. 72200095 Lot 122465 - Inferior Turbinate Blade M4 Rotatable, Straight, w/o Tubing, 11 cm Length, (White) 2.9mm Ref. 18-8290HR(a) Lot 122465, 122440 - Inferior Turbinate Blade, M4 Rotatable, w/Tubing, (White) 2.0mm Ref. 18-82040HR Lot 122289, 122440 - Inferior Turbinate Blade, w/o Tubing (White) 2.9mm Ref. 18-82940(a) Lot 122590, 122482 - Inferior Turbinate Blade, w/o Tubing 2.0mm Ref. 18-82040(a) Lot 122609 - Micro-Joint Gator Blade, Micro Hub, Sterling, 7.6cm, (Orange) 2.0mm Ref. C9960 Lot 123353 - Oval Bur, High Speed, Large Hub, Sterling (Purple) 4.0mm Ref. H9101 Lot 123263 - Oval Bur, High Speed, Large Hub, Sterling (Purple) 5.0mm Ref. H9103RH Lot 123353 - Oval Bur, High Speed, Large Hub, Sterling, 20 Degree Reduced Hood, (Purple) 4.0mm Ref. H9101RH Lot 122592, 122511 - Oval Bur, Large Hub, Sterling, High Speed (Purple) 6.0mm Ref. H9102 Lot 123263, 122592, 122511 - RazorCut (Purple) 3.5mm Ref. 7205317 Lot 122465 - Rhinotec, Spherical Bur, Micro Hub, Sterling 7.6cm, (Blue) 2.9mm Ref. C9911 Lot 123353 - Series 3000 BoneCutter Blade, Full Radius, (Black/Yellow) 4.5mm Ref. 7206011 Lot 122590, 122609, 122465 - Spherical Bur, Large Hub, Sterling, High Speed, (Blue) 3.5mm Ref. H9110 Lot 123263, 122511 - Spherical Bur, Large Hub, Sterling, High Speed, (Blue) 4.5mm Ref. H9111 Lot 123263, 122511 - Synovator (Forest Green) 4.5mm Ref. 7205310 Lot 122609 - Tiger Blade, Large Hub, Sterling, Shaver (Black) 4.2mm Ref. C9242 Lot 122511 - Tricut Blade w/o Tubing, 11cm, (White) 4.0mm Ref. 18-8400(a) Lot 122590, 122482, 123270 - Tricut Blade, M4 Rotatable, w/o Tubing, (White) 4.0mm Ref. 18-84004HR* Lot 122465 - Tricut Blade, M4 Rotatable, w/Tubing, (White) 4.0mm Ref. 18-84004HR Lot 122289, 122440, 122279 - TurboTrimmer Blade (Powder Blue) 4.5mm Ref. 7205315 Lot 122347 - TurboWhisker Blade (Navy Blue) 4.5mm Ref. 7205316 Lot 122590, 122609 - UltraCut Blade, Large Hub, Sterling Shaver, Dual Purpose Blade, (Slate/Grey) 4.2mm Ref. C94505A Lot 123353, 122511 - UltraCut Full Radius Resector, Sterling, Shaver, Large Hub, (Blue/Grey) 5.5 mm Ref. C9415 Lot 122592, 122511 - Vortex Router, Large Hub, Sterling, Hooded, High Speed, (Green) 4.5mm Ref. H9131 Lot 123263, 122592 - Vortex Router, Large Hub, Sterling, Hooded, High Speed, (Dk. Green) 6.0mm Ref. H9132 Lot 123263, 122592
Code Info122590, 122338, 123263, 122347, 123190, 122493, 122594, 122592, 122482, 122490, 122631, 122289, 123353, 122609, 122465, 122440, 123270, 122588, 122518, 122309, 122279, 122278, 122434, 122665, 122511.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity907
Recall NumberZ-1633-2013
Product DescriptionLarge Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
Code Info122347
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity2
Recall NumberZ-1634-2013
Product Description- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument
Code Info122347, 122289, 122322, 122511.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity10
Recall NumberZ-1635-2013
Product Description- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 Passer
Code Info122511, 122631.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity2
Recall NumberZ-1636-2013
Product DescriptionTPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument
Code Info122518, 122447.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity4
Recall NumberZ-1637-2013
Product Description- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715
Code Info122692, 122982, 122986, 122984, 122549, 122985, 122570, 122546, 122547, 122574, 122715.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity229
Recall NumberZ-1638-2013
Product Description- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use
Code Info122429
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity4
Recall NumberZ-1639-2013
Product Description- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.
Code Info123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity34
Recall NumberZ-1640-2013
Product Description- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator, (Orange) 6.5mm x 72mm Ref. 72200427 Lot 122465 - Crystal Cannula w/Obturator (Orange) 5.75mm I.D. X 7cm Ref. AR-6460 Lot 122594, 122518 - Crystal Cannula, Partially Threaded, Distal End, w/Obturator, (Orange) 5.75mm I.D. x 7cm Ref. AR-6564 Lot 122493 - Dry-Doc Cannula System w/ Obturator (Translucent Green) 5.0mm x 85mm Ref. C7350 Lot 123263 - Dry-Doc Cannula w/ Obturator (Translucent Blue) 7.0mm x 85mm Ref. C7360 Lot 123263, 122594 - Instrument Cannula w/Obturator w/"No Squirt Cap", (Purple) 7.0mm I.D. X 7cm Ref. AR-6550 Lot 122590 - Partially Threaded Cannula and Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6567* Lot 123043, 122278 - PassPort Button Cannula" (Blue) 8mm ID x 4cm Ref. AR-6592-08-40 Lot 122594 - Smooth Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214106 Lot 122465 - Threaded Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214108 Lot 122665 - Threaded Clear Cannula w/Obturator (Yellow) 8.5mm x 75mm Ref. 214120 Lot 122440, 122588 - Threaded Clear Cannula w/Obturator, (Purple) 7.0mm x 75mm Ref. 214116 Lot 122465 - Tibial Tunnel Cannula, Accomodates 9-12 mm Tunnel Diameters, (Blue) Ref. AR-1802D Lot 122594, 122279 - Twist-In Cannula w/Obturator w/"No Squirt Cap", (Gold) 8.25mm I.D. X 7cm Ref. AR-6530 Lot 122590, 123190, 122665 - Twist-In Cannula w/Obturator, w/ "No-Squirt" Cap, (Green) 6.0mm I.D. x 7cm Ref. AR-6535 Lot 122590, 122665 - Twist-In Cannula w/Obturator, w/"No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570 Lot 123190 - Twist-In Cannula w/Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570* Lot 123043 - Twist-In Cannula w/Obturator, w/o No Squirt Cap, (Gold) 8.25mm I.D. x 7cm Ref. AR-6530* Lot 122504, 122493, 123043 - Universal Cannula w/Obturator, 76mm long (Green) 7.0mm Ref. 012421 Lot 123043 - Universal Cannula, w/Obturator and Trocar (Blue) 5.0mm I.D. x 76mm Ref. 012405 Lot 123043, 122434 Arthoscope
Code Info122590, 123263, 123190, 122504, 122493, 122594, 123043, 122631, 122609, 122465, 122440, 122588, 122518, 122279, 122278, 122434, 122665.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity73
Recall NumberZ-1641-2013
Product Description- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics® Mini-Flared ABS® Tip, 20 Degree Tip Angle, 45° Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics® Tapered ABS® MicroTip" 30° Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000" Legacy® TurboSonics® Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.
Code Info122590, 123372, 123215, 122309.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity90
Recall NumberZ-1642-2013
Product Description- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 Endoscope and accessories - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338, 122454, 122490, 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490, 122429, 122300 - Kii Optical Access System Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609
Code Info122338, 122347, 122454, 122592, 123372, 122490, 122490, 123254, 122609, 122429, 123215, 122647, 122300.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity259
Recall NumberZ-1643-2013
Product DescriptionHarmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified
Code Info122295, 122308, 122762.
ClassificationClass II
Reason for RecallThe seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product Quantity3
Recall NumberZ-1644-2013

Class II Devices Event

Event ID65207
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrtho-Clinical Diagnostics
CityRochester
StateNY
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain
 

Associated Products

Product Description1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Code InfoSerial numbers: 1) J34000240, J34000714, J34001562 and J34002163 through J34002245, 2) 34000193, 34000420, 34000478, 34000495, 34000497, 34000529, 34000596, 34000799, 34000805, 34000947, 34001243, 34001422, 34001504, 34001569, 34001589, 34001610, 34001633
ClassificationClass II
Reason for RecallThere is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Product QuantityTotal 101 units (84 units for # 6801375- 26 units domestic & 58 units foreign) and (17 units for # 6801890-15 units domestic, 2 units foreign)
Recall NumberZ-1647-2013
Product DescriptionVITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Code InfoSerial numbers: J46000021, J46000110 through J46000177
ClassificationClass II
Reason for RecallThere is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Product QuantityTotal 69 units (28 units domestically and 41 units internationally)
Recall NumberZ-1648-2013
Product DescriptionVITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Code InfoSerial numbers: J56000110, J56000118 and J56001095 through J56001507
ClassificationClass II
Reason for RecallThere is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Product QuantityTotal 381 units ( 227 units domestically & 154 units internationally)
Recall NumberZ-1649-2013
Product DescriptionVITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Code InfoSerial numbers: J36000111 and J36000520 through J36000617
ClassificationClass II
Reason for RecallThere is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Product QuantityTotal 98 units (30 units domestically & 68 units internationally)
Recall NumberZ-1650-2013
Product DescriptionORTHO® Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO® Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and ORTHO Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing.
Code InfoSerial numbers: 0811F06216 through 0811F06225 and 0911F06240 through 0911F06245 and 1011F06317 through 1011F06331
ClassificationClass II
Reason for RecallThere is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Product Quantity31 units
Recall NumberZ-1651-2013

Class II Food Event

Event ID65272
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFlorida Nutri Labs, LLC
CityLakeland
StateFL
CountryUS
Distribution PatternProduct was distributed to 1 distributor, Kirland Science Labs located in Seattle, WA.
 

Associated Products

Product Description"***DIETARY SUPPLEMENT 4HB STACK Mealtime***78 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".
Code InfoLot #12-195, expiration date 12/2014 UPC #0 13964 66250 4
ClassificationClass II
Reason for RecallCustomer reported that a product user complained that the caplets were not coated, making them difficult to swallow.
Product Quantity1982 bottles
Recall NumberF1582-2013
Product Description"***DIETARY SUPPLEMENT 4HB STACK Bedtime***52 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".
Code InfoLot #12-194, expiration date 12/2014 UPC #0 13964 66251 1
ClassificationClass II
Reason for RecallCustomer reported that a product user complained that the caplets were not coated, making them difficult to swallow.
Product Quantity2526 bottles
Recall NumberF1583-2013

Class II Devices Event

Event ID65286
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPenlon, Ltd.
CityAbingdon
State
CountryGB
Distribution PatternWorldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.
 

Associated Products

Product DescriptionDelta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Code InfoAll; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
ClassificationClass II
Reason for RecallIt has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.
Product Quantity9208 (of which 576 were within the US)
Recall NumberZ-1653-2013

Class II Drugs Event

Event ID65288
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxter Healthcare Corp.
CityDeerfield
StateIL
CountryUS
Distribution PatternNationwide & Puerto Rico
 

Associated Products

Product Description0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
Code InfoLot #: a) Product code 2B0042: P285668, P285668A, P285668C, P285734, Exp 5/13; b) Product code 2B0043: P285395, Exp 5/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Product Quantity845,520 units
Recall NumberD-624-2013
Product Description5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015
Code InfoLot #: a) Product code 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Product Quantity730,848 units
Recall NumberD-625-2013
Product DescriptionHeparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015
Code InfoLot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Product Quantity
Recall NumberD-626-2013
Product DescriptionLidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
Code InfoLot #: Product code 2B0973: P279935, Exp 7/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Product Quantity
Recall NumberD-627-2013
Product DescriptionSodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015
Code InfoLot #: a) Product code 2B1301: P279943, P280370, Exp 7/13; b) Product code 2B1302: P280248, P280248A, P280248B, P285346, P285791, Exp 8/13; c) Product code 2B1306: P285601, Exp 5/13; d) Product code 2B1307: P280347, Exp 8/13; e) Product code 2B1308: P280404, P280404A, P285635, P285858, Exp 11/13; e) Product code 2B1309: P280149, Exp 8/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Product Quantity1,788,292 units
Recall NumberD-628-2013
Product DescriptionMetronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Code InfoLot #: P280123, P280123A, Exp 2/14
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Product Quantity172,296 units
Recall NumberD-629-2014

Class II Devices Event

Event ID65301
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.
 

Associated Products

Product DescriptionBigliani/Flatow® The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Code InfoItem Number: 00-4305-019-40 with Lot Numbers 61588143 and 61612276. 2010 Market Withdrawal: Item #:430501940 Lot #'s: 60768814, 60806551, 60893241, 60946820, 60999665, 61031668, 61110808, 61170678, 61205673, 61244194, 61392456, 61430127
ClassificationClass II
Reason for RecallThis is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.
Product Quantity722 units (includes 2010 market withdrawal)
Recall NumberZ-1620-2013
Product DescriptionBigliani/Flatow® The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Code Info Item Number 00-4305-019-30 with Lot Numbers 61557761, 61591732, 61612275, 61614764, and 77000186. 2010 Market Withdrawal part numbers: Item #:430501930, Lot#s: 60795817, 60834923, 60916795, 60997103, 61017041, 61038697, 61075510, 61128521, 61186400, 61199809, 61253702, 61392455, 61430126
ClassificationClass II
Reason for RecallThis is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.
Product Quantity722 units (includes 2010 market withdrawal)
Recall NumberZ-1621-2013

Class II Food Event

Event ID65319
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFood Concepts
CityLebanon
StateTN
CountryUS
Distribution PatternSC
 

Associated Products

Product DescriptionBIG COUNTRY BREAKFAST, CASE WEIGHT 26 LBS., MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087
Code Info0281301 and 0281302
ClassificationClass II
Reason for RecallProducts contain texturized soy protein which was recalled by CHS, Inc. due to possible salmonella contamination.
Product Quantity43 cases
Recall NumberF-1591-2013
Product DescriptionSPANISH SENSATION, NET WEIGHT 32 LBS, MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087
Code Info3101201 and 0351301
ClassificationClass II
Reason for RecallProducts contain texturized soy protein which was recalled by CHS, Inc. due to possible salmonella contamination.
Product Quantity29 cases
Recall NumberF-1592-2013
Product DescriptionRAGIN' CAJUN, WEIGHT 32 LBS, MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087
Code Info0281301, 1191301, and 0351301
ClassificationClass II
Reason for RecallProducts contain texturized soy protein which was recalled by CHS, Inc. due to possible salmonella contamination.
Product Quantity76 cases
Recall NumberF-1593-2013

Class II Food Event

Event ID65327
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmABCO Laboratories, Inc.
CityFairfield
StateCA
CountryUS
Distribution PatternCA and PA.
 

Associated Products

Product DescriptionSoy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer. Finished product was made for Nurti-Cology - Allergy Research Group of Alameda, CA and Vinco Inc. of Evans City PA, both of whom will be conducting their own recalls.
Code Info All Lots 03-25-11 t0 05-21-13
ClassificationClass II
Reason for RecallABCO products are being recalled as part of a larger recall from their supplier of certain soy based products produced in its Ashdod, Israel production facility.
Product Quantity52 lots of finished products, 70 bulk raw material lots.
Recall NumberF-1585-2013

Class II Food Event

Event ID65378
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-13
Initial Firm Notification of Consignee or Public press release
Recalling FirmCheryls
CityWesterville
StateOH
CountryUS
Distribution PatternThe product has been distibuted to 13 military members in Europe and the Pacific regions, as well as customers in these states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
 

Associated Products

Product DescriptionFudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted Cinnamon Pumpkin cookie wrappers, 1.6oz (45g) in size, 1 cookie per package, 100 cookies per case.
Code InfoLot number 88 13 1
ClassificationClass II
Reason for RecallUndeclared allergen due to use of incorrect packaging on peanut butter cookies.
Product Quantity10588
Recall NumberF-1577-2013

Class II Devices Event

Event ID65410
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Feb-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBRAEMAR, INC.
CityEagan
StateMN
CountryUS
Distribution PatternNationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.
 

Associated Products

Product DescriptionLithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
Code Infon/a
ClassificationClass II
Reason for RecallBraemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.
Product Quantity3286 packs
Recall NumberZ-1652-2013

Class II Devices Event

Event ID65418
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMartinez
StateCA
CountryUS
Distribution PatternWorldwide Distribution: USA Nationwide and countries of: Algeria, Angola, Argentina, Austria, Australia, Bahamas, Belgium, Bosnia Herzeg, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hungary, India, Indonesia, Italy, Iran, Iraq, Ireland, Japan, Jordan, Kenya, DPR of Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Pakistan, Palestinian Ter, Peru, Philippines, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sri Lanka, South Africa, Sweden, Switzerlan, Taiwan, Thailand, Trinidad Tobago,Turkey, United Kingdom, Venezula, Vietnam, Rep of Yemen, and Zambia.
 

Associated Products

Product DescriptionSiemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Code InfoAll customers who use the BEAMVIEW for position verification imaging on Siemens MEVATRON series, PRIMART (limited release) PRIMUS and/or ONCOR or ARTIST Linac Systems.
ClassificationClass II
Reason for RecallThe information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients.
Product Quantity1956 customers
Recall NumberZ-1663-2013

Class II Devices Event

Event ID65423
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBRAEMAR, INC.
CityEagan
StateMN
CountryUS
Distribution PatternNationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
 

Associated Products

Product DescriptionLithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
Code Infon/a
ClassificationClass II
Reason for RecallBraemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related injury or present any clinical impact.
Product Quantity10,785 packs
Recall NumberZ-1645-2013

Class II Food Event

Event ID65446
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmHoover Mill, Inc.
CityChipley
StateFL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionARNETT'S PLAIN CORN MEAL NET WT. 24 OZ. (1lb. 8 oz)(680g
Code InfoUPC #70582-10001 Lot # "Sell By 2-21-14" Exp date 2-21-14
ClassificationClass II
Reason for RecallDue to high levels of aflatoxin
Product Quantity6,084 bags
Recall NumberF-1578-2013
Product DescriptionARNETT'S SELF RISING CORN MEAL NET WEIGHT 24 OZ. (1LB. 8 OZ) 680g
Code InfoUPC #70582-20001 Lot # "Sell By 2-21-14" Exp date 2-21-14
ClassificationClass II
Reason for RecallDue to high levels of aflatoxin
Product Quantity7,068 bags
Recall NumberF-1579-2013
Product DescriptionDixie Lily Stone Ground Meal 24 oz & 5lbs
Code Info24 oz-UPC #05663-10739 Lot # "Sell By 2-27-14" ; 5 lbs.-UPC #05663-10239 Lot # "Sell By 3-1-14"
ClassificationClass II
Reason for RecallDue to high levels of aflatoxin
Product Quantity5440 bags
Recall NumberF-1580-2013

Class II Food Event

Event ID65478
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMiddlefield Original Cheese Coop
CityMiddlefield
StateOH
CountryUS
Distribution PatternThe cheese was sold/distributed to Laubscher Cheese 1468 Perry Highway Mercer, PA 16137, contact is Kevin at 800-798-4015; the liquid whey was sold/distributed to Miceli's Cheese 2721 E. 90th St Cleveland, Ohio 44104, contact is Cominick at 800-551-7196 Ext. 125.
 

Associated Products

Product Description40 lbs Cheddar Cheese block wrapped in flexible plastic vacuum packaging, one block per box.
Code InfoEach 40 pound block of cheese had the date code of 05/20/13 and the vat letter. Each box of cheese had the manufacturing plant code 39-073 printed on the box.
ClassificationClass II
Reason for RecallThe raw milk used to manufacture cheese was not tested for the concentration of Beta Lactam antibiotics, which are allergens.
Product Quantity1,540-40 lbs blocks
Recall NumberF-1552-2013
Product DescriptionWhey liquid packaged in unknown containers.
Code InfoNone; the liquid whey is stored in silos and pumped into tankers for shipping. The firm only tracks the volume that is being distributed.
ClassificationClass II
Reason for RecallThe raw milk used to manufacture whey was not tested for the concentration of Beta Lactam antibiotics, which are allergens.
Product Quantity90,100 gallons of sweet whey.
Recall NumberF-1553-2013

Class II Devices Event

Event ID65493
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDJO, LLC
CityVista
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula,
 

Associated Products

Product DescriptionVenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
Code InfoModel Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00050 E00051 E00052 E00053 E00056 E00057 E00058 E00060 E00143 E00147 E00151 E00156 E00163 E00169 E00175 E00178 E00184 E00191 E00200 E00201 E00203 E00205 E00206 E00211 E00211 E00222 E00227 E00234 E00236 E00238 E00239 E00240 E00241 E00242 E00243 E00245 E00246 E00247 E00248 E00250 E00252 E00258 E00260 E00261 E00262 E00264 E00267 E00269 E00271 E00272 E00273 E00274 E00276 E00281 E00283 E00289 E00296 E00298 E00301 E00303 E00305 E00306 E00308 E00313 E00314 E00315 E00317 E00321 E00322 E00326 E00329 E00330 E00332 E00335 E00336 E00337 E00339 E00340 E00342 E00344 E00347 E00348 E00351 E00352 E00357 E00358 E00363 E00368 E00370 E00371 E00373 E00375 E00376 E00377 E00379 E00380 E00381 E00384 E00385 E00388 E00390 E00391 E00392 E00393 E00394 E00395 E00396 E00397 E00398 E00399 E00400 E00401 E00402 E00403 E00404 E00406 E00407 E00408 E00409 E00410 E00411 E00412 E00413 E00414 E00415 E00416 E00417 E00418 E00419 E00420 E00422 E00426 E00429 E00430 E00432 E00433 E00434 E00436 E00437 E00439 E00492 E00503 E00516 E00529 E00533 E00540 E00541 E00543 E00546 E00548 E00559 E00563 E00570 E00576 E00577 E00580 E00582 E00583 E00584 E00585 E00589 E00590 E00591 E00594 E00595 E00596 E00598 E00599 E00600 E00602 E00604 E00605 E00606 E00607 E00608 E00609 E00610 E00611 E00612 E00613 E00614 E00615 E00616 E00617 E00618 E00619 E00620 E00621 E00622 E00623 E00628 E00629 E00630 E00631 E00632 E00634 E00635 E00636 E00637 E00638 E00639 E00642 E00643 E00644 E00645 E00646 E00647 E00649 E00651 E00652 E00656 E00657 E00658 E00659 E00660 E00661 E00662 E00663 E00664 E00665 E00666 E00669 E00670 E00672 E00673 E00675 E00676 E00677 E00679 E00680 E00682 E00683 E00686 E00687 E00688 E00689 E00692 E00693 E00696 E00698 E00699 E00700 E00701 E00703 E00704 E00705 E00706 E00707 E00708 E00710 E00712 E00714 E00715 E00716 E00718 E00719 E00720 E00723 E00724 E00725 E00727 E00728 E00730 E00733 E00734 E00735 E00736 E00737 E00739 E00740 E00741 E00743 E00744 E00745 E00746 E00747 E00748 E00749 E00750 E00752 E00759 E00760 E00761 E00762 E00763 E00764 E00765 E00766 E00767 E00768 E00769 E00770 E00771 E00772 E00773 E00774 E00775 E00778 E00779 E00786 E00787 E00789 E00791 E00795 E00796 E00797 E00798 E00800 E00806 E00809 E00811 E00812 E00813 E00815 E00822 E00839 E01016 E01018 E01019 E01020 E01021 E01022 E01023 E01024 E01025 E01027 E01028 E01029 E01030 E01032 E01033 E01035 E01036 E01037 E01038 E01041 E01042 E01043 E01044 E01045 E01046 E01047 E01048 E01051 E01053 E01054 E01055 E01057 E01058 E01059 E01060 E01061 E01062 E01063 E01064 E01065 E01066 E01067 E01068 E01071 E01072 E01074 E01076 E01079 E01080 E01081 E01082 E01083 E01084 E01085 E01086 E01087 E01088 E01089 E01090 E01092 E01093 E01094 E01095 E01097 E01098 E01099 E01101 E01102 E01103 E01104 E01105 E01166 E01167 E01168 E01169 E01170 E01171 E01172 E01173 E01174 E01175 E01176 E01177 E01179 E01180 E01183 E01186 E01188 E01189 E01190 E01191 E01192 E01193 E01194 E01195 E01196 E01198 E01200 E01201 E01204 E01205 E01206 E01207 E01208 E01209 E01211 E01212 E01213 E01217 E01219 E01221 E01224 E01226 E01228 E01229 E01230 E01231 E01232 E01234 E01235 E01238 E01239 E01240 E01242 E01245 E01247 E01248 E01249 E01250 E01251 E01252 E01253 E01254 E01456 E01457 E01458 E01459 E01460 E01461 E01462 E01463 E01464 E01466 E01467 E01468 E01469 E01470 E01472 E01474 E01475 E01476 E01477 E01479 E01480 E01481 E01482 E01483 E01484 E01485 E01486 E01488 E01490 E01491 E01494 E01495 E01496 E01500 E01503 E01505 E01507 E01508 E01511 E01512 E01513 E01514 E01516 E01517 E01518 E01520 E01522 E01524 E01525 E01529 E01531 E01532 E01535 E01536 E01537 E01540 E01542 E01543 E01544 E01545 E01546 E01547 E01548 E01549 E01550 E01551 E01552 E01554 E01556 E01557 E01558 E01560 E01561 E01562 E01563 E01566 E01568 E01570 E01571 E01576 E01579 E01581 E01582 E01584 E01585 E01586 E01589 E01590 E01591 E01593 E01594 E01595 E01597 E01598 E01601 E01602 E01605 E01606 E01610 E01611 E01612 E01615 E01617 E01618 E01620 E01624 E01627 E01629 E01630 E01631 E01633 E01634 E01636 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E19763 E19764 E19765 E19767 E19768 E19769 E19770 E19771 E19772 E19773 E19774 E19775 E19776 E19777 E19778 E19779 E19780 E19781 E19782 E19800 E19801 E19802 E19803 E19804 E19805 E19807 E19808 E19809 E19823 E19824 E20319 E20320 E20321 E20324 E20325 E20329 E20330 E20331 E20357 E20359 E20360 E20361 E20362 E20363 E20364 E20365 E20366 E20367 E20368 E20369 E20370 E20371 E20372 E20373 E20374 E20375 E20376 E20377 E20378 E20379 E20381 E20745 E20747 E20749 E20752 E20781 E20785 E20788 EO4491 EO5095 EO5384 EO5408 E10710 E10719 E10748 E13374 E13375 E13376 E13377 E14676 E14874
ClassificationClass II
Reason for RecallDJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).
Product Quantity2491
Recall NumberZ-1661-2013

Class II Devices Event

Event ID65506
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiosense Webster, Inc.
CityIrwindale
StateCA
CountryUS
Distribution PatternDistributed in the states of MN, FL, and UT.
 

Associated Products

Product Description20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Code InfoLot # 15832314L
ClassificationClass II
Reason for RecallBiosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.
Product Quantity10 units
Recall NumberZ-1617-2013

Class III Biologics Event

Event ID41143
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info09GP11509; 09GP11509
ClassificationClass III
Reason for RecallBlood products, collected using an expired blood collection set, were distributed.
Product Quantity2 Units
Recall NumberB-1285-13

Class III Biologics Event

Event ID41832
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info5203937
ClassificationClass III
Reason for RecallBlood product, collected from a donor who was at risk for leishmaniasis, was distributed.
Product Quantity1 unit
Recall NumberB-1693-13

Class III Biologics Event

Event ID42697
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jul-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMO; AR; NJ
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code Info6541216;6568175; 6471644; 6500266; 4243041
ClassificationClass III
Reason for RecallBlood products, manufactured from Whole Blood units with extended collection times, were distributed.
Product Quantity5 Units
Recall NumberB-1688-13
Product DescriptionPlatelets
Code Info6567735; 6554449; 6566610; 6488930; 6583196; 6471337; 6473459; 6487193; 6484513; 6504761; 6521015; 6617680; 6653373; 6708255; 4243318; 6617693; 6627057; 6517604; 6519075; 6518981; 6515638; 6487190; 6497614; 6464517; 6562334; 6477701; 6514649; 6692573; 6592478; 6661580; 6563569; 6559270; 6521050; 6497071
ClassificationClass III
Reason for RecallBlood products, manufactured from Whole Blood units with extended collection times, were distributed.
Product Quantity34 Units
Recall NumberB-1689-13
Product DescriptionFresh Frozen Plasma
Code Info6562334; 6705196; 4243318; 6482869; 6497071; 6614538; 6496289; 6488930; 6559270; 6467217; 6524060; 6566610; 6582088; 6663526; 6476275; 6617680; 6610450; 6589186; 6464517; 6487193; 6547651; 6592478; 6473459; 6481957; 6495497; 6504761; 6517604; 6554011; 6565663; 6555912; 6567735; 6585224; 6697679; 6692573; 6570898; 6691603; 6617693; 6583196; 6477701; 6471337; 6708255
ClassificationClass III
Reason for RecallBlood products, manufactured from Whole Blood units with extended collection times, were distributed.
Product Quantity41 Units
Recall NumberB-1690-13
Product DescriptionPlasma Cryoprecipitate Reduced
Code Info6568175
ClassificationClass III
Reason for RecallBlood products, manufactured from Whole Blood units with extended collection times, were distributed.
Product Quantity1 Unit
Recall NumberB-1691-13
Product DescriptionRed Blood Cells Leukocytes Reduced Washed
Code Info6476878
ClassificationClass III
Reason for RecallBlood products, manufactured from Whole Blood units with extended collection times, were distributed.
Product Quantity1 Unit
Recall NumberB-1692-13

Class III Biologics Event

Event ID44986
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida Georgia Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info8604438; 8604441; 7807659; 7808666.
ClassificationClass III
Reason for RecallBlood products, for which there was no documentation for the time period out of controlled storage, were distributed.
Product Quantity4 units
Recall NumberB-1662-13

Class III Biologics Event

Event ID46676
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Blood Alliance, Inc.
CitySaint Augustine
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info4826808; 7807745; 9870298, 9868793, 1957226.
ClassificationClass III
Reason for RecallBlood products, for which there was no documentation for the time period out of controlled storage, were distributed.
Product Quantity5 units
Recall NumberB-1660-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info8604481; 8604477; 8604418; 1251960; 8604227; 7807516; 7807522; 8604129; 8604171; 7807314; 7806375; 7806344; 5924178; 7806218; 7806202, 7805994, 7805982, 7805959, 4805907, 8603589, 7805765, 7805758, 7805752, 4208542, 7426585, 8603492, 7805649, 7805593, 7805591, 7805542
ClassificationClass III
Reason for RecallBlood products, for which there was no documentation for the time period out of controlled storage, were distributed.
Product Quantity30 units
Recall NumberB-1661-13

Class III Biologics Event

Event ID49228
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternPA and NY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01LE52991; 01LV90232
ClassificationClass III
Reason for RecallBlood products, collected from a donor who traveled to a malarial and leishmaniasis endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1292-13

Class III Biologics Event

Event ID49741
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTalecris Plasma Resources, Inc.
CityColorado Springs
StateCO
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info033107151A; 033108101; 033108102; 033108103; 033108104; 033108105; 033108106; 033108108; 033108109; 033108107
ClassificationClass III
Reason for RecallBlood products, which reached unacceptable temperatures during storage, were distributed.
Product Quantity10 vender batches
Recall NumberB-1286-13

Class III Biologics Event

Event ID49991
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Washed
Code Info001Y66804; 001KS73999
ClassificationClass III
Reason for RecallBlood products, not prepared in accordance with specifications, were distributed.
Product Quantity2 units
Recall NumberB-1372-13

Class III Biologics Event

Event ID52243
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jun-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTalecris Plasma Resources, Inc.
CityColorado Springs
StateCO
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info366113033; 366113309; 366111020; 366113237; 366113323; 366113372; 366111532; 366111640; 366111454; 366111033; 366113367; 366113916; 366113408; 366113038; 366111459; 366111050; 366111350; 366113332; 366111046, 366111331, 366111465, 366111458, 366113227, 366111560, 366111361, 366111330, 366113919, 366111008, 366113395, 366111653, 366111340, 366113013, 366111364, 366113209, 366113984, 366111646, 366113311, 366111004, 366111042, 366111635, 366113895, 366113500, 366113307, 366113845, 366111052, 366111469, 366113320, 366113906.
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity48 units
Recall NumberB-1542-13

Class III Biologics Event

Event ID58781
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-May-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBioLife Plasma Services L.P.
CitySpringfield
StateMO
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info07FMOD4621; 07FMOD3544; 07FMOD2181; 07FMOD1338; 07FMOC0376; 07FMOB7154; 07FMOB5860; 07FMOB1859; 07FMOB1539; 07FMOB0637; 07FMOB0312; 07FMOA9472; 07FMOA8985; 07FMOA7595; 07FMOA7095; 07FMOA6600; 07FMOA2585; 07FMOB6257; 07FMOA1992; 07FMOA0725; 06FMOE5032
ClassificationClass III
Reason for RecallBlood products, collected from a donor with a history of brain surgery, were distributed.
Product Quantity21 units
Recall NumberB-1530-13

Class III Food Event

Event ID63455
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAlymaq Inc
CityLaredo
StateTX
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionALYMAQ EXTRA FINE GRANULATED SUGAR AIB, www.alymaq.com, NET WT. 50 LBS. (22.68KG), KEEP IN A COOL AND DRY PLACE. Multi-wall polyethylene lined bag. 55 bags per pallet.
Code InfoLot EFG1007924
ClassificationClass III
Reason for RecallProduct has the potential to contain plastic fragments.
Product Quantity770 bags
Recall NumberF-1581-2013

Class III Biologics Event

Event ID64613
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc
CityMonroe
StateLA
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info3800245198; 3800245032
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1525-13

Class III Biologics Event

Event ID64905
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross
CityColumbus
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info16KC44866
ClassificationClass III
Reason for RecallBlood product, manufactured without additive solution, was distributed.
Product Quantity1 unit
Recall NumberB-1634-13

Class III Drugs Event

Event ID65393
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPfizer Inc.
CityNew York
StateNY
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionPrempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA
Code InfoLots: E67324 & E96152 Exp: 06/13
ClassificationClass III
Reason for RecallFailed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
Product Quantity432,657 blister cards
Recall NumberD-630-2013
Product DescriptionPrempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0875-11
Code InfoLots: E77055, E96153, & F11111 Exp: 06/13
ClassificationClass III
Reason for RecallFailed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
Product Quantity135,520 blister cards
Recall NumberD-631-2013

Class III Devices Event

Event ID65431
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
 

Associated Products

Product DescriptionBD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Code InfoSerial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272
ClassificationClass III
Reason for RecallElectrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Product Quantity71 instruments
Recall NumberZ-1662-2013

Mixed Classification Biologics Event

Event ID48941
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info01KT10802
ClassificationClass III
Reason for RecallBlood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1663-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01KT10802
ClassificationClass II
Reason for RecallBlood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1664-13

Mixed Classification Biologics Event

Event ID64612
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTN, NY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoP67796
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1508-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoP67796
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1509-13
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