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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Class I Veterinary Event

Event ID63041
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDairy Farmers Of America, Inc.
CityGoshen
StateIN
CountryUS
Distribution PatternGoshen, IN, Hillsboro, WI, and Reedsburg, WI.
 

Associated Products

Product DescriptionDFA (Dairy Farmers of America), non-fat dry milk intended and labeled as animal feed 50 lb bags
Code InfoLot Numbers: 1970, 1980, 2000, 2010
ClassificationClass I
Reason for RecallThe product may be contaminated with Salmonella.
Product Quantity24,415 lbs
Recall NumberV-111-2013

Class I Veterinary Event

Event ID63135
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmQuality Feed, Inc
CityDousman
StateWI
CountryUS
Distribution PatternIL, MN, IN, NY, OH, PA, WI
 

Associated Products

Product DescriptionPEACHEY'S 20/20 AM NM MILK REPLACER,"ALL MILK", Manufactured for: Peachey's 638 Bunker Hill Road, Belleville, PA #122, NET WEIGHT 50 LBS (22.7Kg).
Code Info100222
ClassificationClass I
Reason for RecallQuality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella.
Product Quantity3 TONS
Recall NumberV-105-2013
Product DescriptionYO-MOMMA 26/24 AM NM MILK REPLACER., Manufactured for Agri Support Inc., 8137 Royal Oaks Road, Rockford, IL 61107 #126, NET WEIGHT 50 LBS (22.7 Kg).
Code Info070307-080308
ClassificationClass I
Reason for RecallQuality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella.
Product Quantity6 TONS
Recall NumberV-106-2013
Product DescriptionQUALITY FEEDS INCORPORATED 20/20 AM, ., Manufactured for Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118 Pin #2021, NET WEIGHT 50 LBS (22.7 Kg).
Code Info070124-080124; 010127-030127; 010131-020131; 100207; 020216; 120220-130220; 100220-110220; 050227-070227; 040308-070308; 060314-070314; and 070321-080321
ClassificationClass I
Reason for RecallQuality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella.
Product Quantity72 TONS
Recall NumberV-107-2013
Product DescriptionDAIRY PRINCESS "ACCELERATED" , 23/18 AM MILK REPLACER MEDICATED, Manufactured for Nelson Dairy Consultants, Inc., Holtz Nelson Dairy Consultants, LLC., 115 Washington Street, Decorah, IA 52101 #208, NET WEIGHT 50 LBS (22.7 Kg).
Code Info010307-040307 and 010309
ClassificationClass I
Reason for RecallQuality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella.
Product Quantity15 TONS
Recall NumberV-108-2013
Product DescriptionQUALITY FEED INC., STARTER PLUS, 20/17 , MILK REPLACER, Manufactured by Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118, NET WEIGHT 50 LBS (22.7 Kg).
Code Info040127-060127; 030206-040206; 040220-060220; 050302; and 010227-040227
ClassificationClass I
Reason for RecallQuality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella.
Product Quantity39 TONS
Recall NumberV-109-2013
Product DescriptionQUALITY FEED INC., FINISHER PLUS 16/18 , MILK REPLACER , Manufactured by Quality Feed, Inc., 151 S. Main Street, Dousman, WI 53118, NET WEIGHT 50 LBS (22.7 Kg).
Code Info030201-060201; 010202-020202; 050206-080206; 010221-040221; 060223-110223; 010224-100224; 010228-100228; 050229-090229; 010301-050301; 060301-150301; 010313-080313; 010315-080315; 010321-040321; 090321-120321; 010322-100322; 010229-040229; and 050222-080222
ClassificationClass I
Reason for RecallQuality Feed. Inc. is recalling milk replacer that was shipped between January 31, 2012 and March 31, 2012 because it has the potential to be contaminated with Salmonella.
Product Quantity303 TONS
Recall NumberV-110-2013

Class I Drugs Event

Event ID63138
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmVintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
CityHuntsville
StateAL
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionHYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
Code InfoLot number: C1440512A, Exp 12/13
ClassificationClass I
Reason for RecallSuperpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Product Quantity14,445 bottles
Recall NumberD-057-2013

Class I Drugs Event

Event ID63246
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmWatson Laboratories Inc
CityCorona
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionHydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
Code InfoLot #: 519406A, 521759A, Exp 04/14
ClassificationClass I
Reason for RecallSuperpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Product Quantity4,874 bottles
Recall NumberD-058-2013

Class I Devices Event

Event ID63314
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMindray DS USA, Inc. d.b.a. Mindray North America
CityMahwah
StateNJ
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
 

Associated Products

Product DescriptionMindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
Code Info0633F-01000-00 Various serial numbers 0633F-01000-00 FA-1A000033 0633F-01000-00 FA-1A000023 0633F-01000-00 FA-21000072 0633F-01000-00 FA-1A000029 0633F-01000-00 FA-21000085 0633F-01000-00 FA-19000011 0633F-01000-00 FA-19000008 0633F-01000-00 FA-19000009 0633F-01000-00 FA-1A000027 0633F-01000-00 FA-1A000047 0633F-01000-00 FA-1A000055 0633F-01000-00 FA-1A000041 0633F-01000-00 FA-1A000053 0633F-01000-00 FA-1B000056 0633F-01000-00 FA-21000080 0633F-01000-00 FA-19000007 0633F-01000-00 FA-19000013 0633F-01000-00 FA-21000066 0633F-01000-00 FA-21000078 0633F-01000-00 FA-19000012 0633F-01000-00 FA-19000017 0633F-01000-00 FA-1A000021 0633F-01000-00 FA-1A000028 0633F-01000-00 FA-1A000038 0633F-01000-00 FA-1A000045 0633F-01000-00 FA-1A000035 0633F-01000-00 FA-1A000037 0633F-01000-00 FA-1A000026 0633F-01000-00 FA-1A000030 0633F-01000-00 FA-1A000048 0633F-01000-00 FA-1A000040 0633F-01000-00 FA-1B000059 0633F-01000-00 FA-1A000034 0633F-01000-00 FA-1A000049 0633F-01000-00 FA-21000062 0633F-01000-00 FA-21000064 0633F-01000-00 FA-21000074 0633F-01000-00 FA-21000082 0633F-01000-00 FA-21000090 0633F-01000-00 FA-1A000022 0633F-01000-00 FA-1A000051 0633F-01000-00 FA-1A000052 0633F-01000-00 FA-1A000042 0633F-01000-00 FA-1A000050 0633F-01000-00 FA-1B000057 0633F-01000-00 FA-1B000061 0633F-01000-00 FA-1A000025 0633F-01000-00 FA-1A000031 0633F-01000-00 FA-1A000036 0633F-01000-00 FA-1A000044 0633F-01000-00 FA-21000076 0633F-01000-00 FA-21000077 0633F-01000-00 FA-21000088 0633F-01000-00 FA-1A000043 0633F-01000-00 FA-1A000032 0633F-01000-00 FA-1A000046 0633F-01000-00 FA-1B000058 0633F-01000-00 FA-1B000060 0633F-01000-00 FA-19000010 0633F-01000-00 FA-19000015 0633F-01000-00 FA-21000086
ClassificationClass I
Reason for RecallMindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
Product Quantity69 units (61 US - 8 Foreign)
Recall NumberZ-0290-2013
Product DescriptionMindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
Code Info0631F-01000-00 Various serial numbers 0631F-01000-00 EJ-1A001411 0631F-01000-00 EJ-1A001426 0631F-01000-00 EJ-1A001431 0631F-01000-00 EJ-1A001439 0631F-01000-00 EJ-1A001443 0631F-01000-00 EJ-1C001577 0631F-01000-00 EJ-1C001592 0631F-01000-00 EJ-1C001593 0631F-01000-00 EJ-1C001622 0631F-01000-00 EJ-1A001469 0631F-01000-00 EJ-1A001416 0631F-01000-00 EJ-1A001423 0631F-01000-00 EJ-1B001497 0631F-01000-00 EJ-1B001519 0631F-01000-00 EJ-1B001524 0631F-01000-00 EJ-1B001538 0631F-01000-00 EJ-1B001544 0631F-01000-00 EJ-1B001546 0631F-01000-00 EJ-1B001549 0631F-01000-00 EJ-1B001550 0631F-01000-00 EJ-1C001572 0631F-01000-00 EJ-1C001617 0631F-01000-00 EJ-22001684 0631F-01000-00 EJ-1B001540 0631F-01000-00 EJ-1B001548 0631F-01000-00 EJ-21001634 0631F-01000-00 EJ-21001641 0631F-01000-00 EJ-21001642 0631F-01000-00 EJ-21001644 0631F-01000-00 EJ-21001650 0631F-01000-00 EJ-21001643 0631F-01000-00 EJ-21001654 0631F-01000-00 EJ-22001704 0631F-01000-00 EJ-23001760 0631F-01000-00 EJ-23001765 0631F-01000-00 EJ-23001775 0631F-01000-00 EJ-1A001437 0631F-01000-00 EJ-1A001445 0631F-01000-00 EJ-22001710 0631F-01000-00 EJ-22001724 0631F-01000-00 EJ-22001743 0631F-01000-00 EJ-1A001418 0631F-01000-00 EJ-1B001511 0631F-01000-00 EJ-23001764 0631F-01000-00 EJ-23001768 0631F-01000-00 EJ-23001769 0631F-01000-00 EJ-23001779 0631F-01000-00 EJ-23001792 0631F-01000-00 EJ-22001696 0631F-01000-00 EJ-22001701 0631F-01000-00 EJ-22001705 0631F-01000-00 EJ-22001707 0631F-01000-00 EJ-22001723 0631F-01000-00 EJ-1C001573 0631F-01000-00 EJ-1C001589 0631F-01000-00 EJ-1C001590 0631F-01000-00 EJ-1C001599 0631F-01000-00 EJ-1C001610 0631F-01000-00 EJ-1C001619 0631F-01000-00 EJ-21001667 0631F-01000-00 EJ-22001679 0631F-01000-00 EJ-22001686 0631F-01000-00 EJ-22001688 0631F-01000-00 EJ-22001721 0631F-01000-00 EJ-15001187 0631F-01000-00 EJ-1A001420 0631F-01000-00 EJ-22001699 0631F-01000-00 EJ-1B001512 0631F-01000-00 EJ-1A001459 0631F-01000-00 EJ-21001635 0631F-01000-00 EJ-21001636 0631F-01000-00 EJ-21001637 0631F-01000-00 EJ-21001658 0631F-01000-00 EJ-22001681 0631F-01000-00 EJ-22001692 0631F-01000-00 EJ-22001693 0631F-01000-00 EJ-22001698 0631F-01000-00 EJ-22001700 0631F-01000-00 EJ-22001703 0631F-01000-00 EJ-22001712 0631F-01000-00 EJ-22001734 0631F-01000-00 EJ-22001741 0631F-01000-00 EJ-1A001449 0631F-01000-00 EJ-1A001471 0631F-01000-00 EJ-1A001478 0631F-01000-00 EJ-1A001479 0631F-01000-00 EJ-1A001440 0631F-01000-00 EJ-1C001585 0631F-01000-00 EJ-1A001473 0631F-01000-00 EJ-1A001438 0631F-01000-00 EJ-1A001442 0631F-01000-00 EJ-1A001456 0631F-01000-00 EJ-1A001474 0631F-01000-00 EJ-1A001463 0631F-01000-00 EJ-1B001559 0631F-01000-00 EJ-1B001564 0631F-01000-00 EJ-1B001496 0631F-01000-00 EJ-1A001446 0631F-01000-00 EJ-23001757 0631F-01000-00 EJ-1A001421 0631F-01000-00 EJ-1A001424 0631F-01000-00 EJ-23001753 0631F-01000-00 EJ-1A001462 0631F-01000-00 EJ-1A001480 0631F-01000-00 EJ-1A001484 0631F-01000-00 EJ-21001657 0631F-01000-00 EJ-21001662 0631F-01000-00 EJ-21001670 0631F-01000-00 EJ-22001675 0631F-01000-00 EJ-22001676 0631F-01000-00 EJ-22001689 0631F-01000-00 EJ-22001694 0631F-01000-00 EJ-22001697 0631F-01000-00 EJ-22001702 0631F-01000-00 EJ-22001708 0631F-01000-00 EJ-22001713 0631F-01000-00 EJ-22001716 0631F-01000-00 EJ-22001717 0631F-01000-00 EJ-22001718 0631F-01000-00 EJ-22001720 0631F-01000-00 EJ-22001722 0631F-01000-00 EJ-22001727 0631F-01000-00 EJ-22001736 0631F-01000-00 EJ-22001740 0631F-01000-00 EJ-23001762 0631F-01000-00 EJ-23001778 0631F-01000-00 EJ-23001783 0631F-01000-00 EJ-1B001514 0631F-01000-00 EJ-1B001518 0631F-01000-00 EJ-1B001523 0631F-01000-00 EJ-1B001526 0631F-01000-00 EJ-1C001597 0631F-01000-00 EJ-1C001606 0631F-01000-00 EJ-23001750 0631F-01000-00 EJ-23001767 0631F-01000-00 EJ-23001772 0631F-01000-00 EJ-23001777 0631F-01000-00 EJ-22001732 0631F-01000-00 EJ-22001745 0631F-01000-00 EJ-23001766 0631F-01000-00 EJ-23001773 0631F-01000-00 EJ-23001780 0631F-01000-00 EJ-23001782 0631F-01000-00 EJ-23001786 0631F-01000-00 EJ-21001656 0631F-01000-00 EJ-21001660 0631F-01000-00 EJ-23001755 0631F-01000-00 EJ-23001761 0631F-01000-00 EJ-1A001435 0631F-01000-00 EJ-22001682 0631F-01000-00 EJ-22001730 0631F-01000-00 EJ-22001737 0631F-01000-00 EJ-23001747 0631F-01000-00 EJ-23001751 0631F-01000-00 EJ-23001756 0631F-01000-00 EJ-1A001447 0631F-01000-00 EJ-1A001450 0631F-01000-00 EJ-1A001455 0631F-01000-00 EJ-22001711 0631F-01000-00 EJ-1A001434 0631F-01000-00 EJ-1B001532 0631F-01000-00 EJ-1B001533 0631F-01000-00 EJ-1A001419 0631F-01000-00 EJ-1B001493 0631F-01000-00 EJ-1B001507 0631F-01000-00 EJ-1B001528 0631F-01000-00 EJ-1A001444 0631F-01000-00 EJ-1B001502 0631F-01000-00 EJ-1A001453 0631F-01000-00 EJ-1A001467 0631F-01000-00 EJ-1B001498 0631F-01000-00 EJ-1B001506 0631F-01000-00 EJ-23001749 0631F-01000-00 EJ-23001759 0631F-01000-00 EJ-23001763 0631F-01000-00 EJ-23001771 0631F-01000-00 EJ-23001784 0631F-01000-00 EJ-1C001574 0631F-01000-00 EJ-1C001580 0631F-01000-00 EJ-1C001588 0631F-01000-00 EJ-1C001591 0631F-01000-00 EJ-1C001594 0631F-01000-00 EJ-1C001598 0631F-01000-00 EJ-22001714 0631F-01000-00 EJ-23001774 0631F-01000-00 EJ-1A001412 0631F-01000-00 EJ-1A001422 0631F-01000-00 EJ-1A001425 0631F-01000-00 EJ-1C001570 0631F-01000-00 EJ-1C001611 0631F-01000-00 EJ-1C001612 0631F-01000-00 EJ-1B001555 0631F-01000-00 EJ-1B001556 0631F-01000-00 EJ-1C001566 0631F-01000-00 EJ-1C001567 0631F-01000-00 EJ-1C001613 0631F-01000-00 EJ-1B001541 0631F-01000-00 EJ-1C001571 0631F-01000-00 EJ-1C001578 0631F-01000-00 EJ-1C001586 0631F-01000-00 EJ-1C001596 0631F-01000-00 EJ-1C001607 0631F-01000-00 EJ-1C001609 0631F-01000-00 EJ-1C001614 0631F-01000-00 EJ-1C001615 0631F-01000-00 EJ-1C001616 0631F-01000-00 EJ-1C001618 0631F-01000-00 EJ-1C001620 0631F-01000-00 EJ-1C001621 0631F-01000-00 EJ-1C001623 0631F-01000-00 EJ-1C001626 0631F-01000-00 EJ-1C001628 0631F-01000-00 EJ-1C001629 0631F-01000-00 EJ-1C001630 0631F-01000-00 EJ-21001669 0631F-01000-00 EJ-21001671 0631F-01000-00 EJ-21001672 0631F-01000-00 EJ-1A001430 0631F-01000-00 EJ-1A001441 0631F-01000-00 EJ-23001770 0631F-01000-00 EJ-23001785 0631F-01000-00 EJ-22001729 0631F-01000-00 EJ-22001739 0631F-01000-00 EJ-23001746 0631F-01000-00 EJ-23001748 0631F-01000-00 EJ-23001754 0631F-01000-00 EJ-23001758 0631F-01000-00 EJ-1A001413 0631F-01000-00 EJ-1A001417 0631F-01000-00 EJ-1A001458 0631F-01000-00 EJ-1A001485 0631F-01000-00 EJ-1B001520 0631F-01000-00 EJ-21001645 0631F-01000-00 EJ-21001663 0631F-01000-00 EJ-21001665 0631F-01000-00 EJ-21001666 0631F-01000-00 EJ-1B001491 0631F-01000-00 EJ-1B001494 0631F-01000-00 EJ-1B001503 0631F-01000-00 EJ-1B001508 0631F-01000-00 EJ-1B001513 0631F-01000-00 EJ-1B001522 0631F-01000-00 EJ-1B001525 0631F-01000-00 EJ-21001649 0631F-01000-00 EJ-22001680 0631F-01000-00 EJ-22001715 0631F-01000-00 EJ-1A001464 0631F-01000-00 EJ-21001673 0631F-01000-00 EJ-21001674 0631F-01000-00 EJ-1B001529 0631F-01000-00 EJ-1C001627 0631F-01000-00 EJ-21001638 0631F-01000-00 EJ-21001661 0631F-01000-00 EJ-21001664 0631F-01000-00 EJ-21001668 0631F-01000-00 EJ-1A001472 0631F-01000-00 EJ-1A001486 0631F-01000-00 EJ-1B001490 0631F-01000-00 EJ-1B001495 0631F-01000-00 EJ-1A001448 0631F-01000-00 EJ-1A001452 0631F-01000-00 EJ-1A001454 0631F-01000-00 EJ-1A001466 0631F-01000-00 EJ-1A001477 0631F-01000-00 EJ-1B001534 0631F-01000-00 EJ-1B001547 0631F-01000-00 EJ-1C001575 0631F-01000-00 EJ-1A001414 0631F-01000-00 EJ-1A001429 0631F-01000-00 EJ-1B001515 0631F-01000-00 EJ-1B001517 0631F-01000-00 EJ-1B001545 0631F-01000-00 EJ-1B001489 0631F-01000-00 EJ-1B001492 0631F-01000-00 EJ-1B001504 0631F-01000-00 EJ-1B001531 0631F-01000-00 EJ-1B001521 0631F-01000-00 EJ-1A001415 0631F-01000-00 EJ-1B001510 0631F-01000-00 EJ-1B001536 0631F-01000-00 EJ-1A001457 0631F-01000-00 EJ-1A001468 0631F-01000-00 EJ-1B001557 0631F-01000-00 EJ-1B001558 0631F-01000-00 EJ-1B001560 0631F-01000-00 EJ-1C001587 0631F-01000-00 EJ-1C001595 0631F-01000-00 EJ-1B001563 0631F-01000-00 EJ-1C001568 0631F-01000-00 EJ-1C001579 0631F-01000-00 EJ-22001687 0631F-01000-00 EJ-1A001481 0631F-01000-00 EJ-1A001451 0631F-01000-00 EJ-1A001460 0631F-01000-00 EJ-1A001461 0631F-01000-00 EJ-1A001470 0631F-01000-00 EJ-1A001428 0631F-01000-00 EJ-1A001433 0631F-01000-00 EJ-1B001501 0631F-01000-00 EJ-1B001505 0631F-01000-00 EJ-1B001509 0631F-01000-00 EJ-22001691 0631F-01000-00 EJ-22001695 0631F-01000-00 EJ-22001706 0631F-01000-00 EJ-22001719 0631F-01000-00 EJ-22001726 0631F-01000-00 EJ-22001728 0631F-01000-00 EJ-22001731 0631F-01000-00 EJ-22001733 0631F-01000-00 EJ-22001735 0631F-01000-00 EJ-22001738
ClassificationClass I
Reason for RecallMindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
Product Quantity346 units (311 US - 35 Foreign)
Recall NumberZ-0291-2013

Class I Devices Event

Event ID63322
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEthicon, Inc.
CitySomerville
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.
 

Associated Products

Product DescriptionETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.
Code InfoPMA: P990004 Medical Device Listing Number: D100622 Product Code 2993 Lot/Batch Numbers: 239346 Exp Jan-13 239411 Exp Jun-13
ClassificationClass I
Reason for RecallSURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
Product Quantity 28,276
Recall NumberZ-0292-2013
Product DescriptionETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
Code InfoPMA number P990004 Medical Device Listing Number D100622 Product Code: 2991 Lot # 239091 Exp Mar-13 Lot # 238783 Exp Sep-13 Lot # 238635 Exp Mar-13 Lot # 237498 Exp Mar-13 Lot # 237119 Exp Mar-13 Lot # 235488 Exp Jan-13
ClassificationClass I
Reason for RecallSURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
Product Quantity 45,200
Recall NumberZ-0293-2013

Class I Food Event

Event ID63499
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmGilster-Mary Lee Corp.
CityChester
StateIL
CountryUS
Distribution PatternDistribution was made to two distribution centers one in TX and one in NC. Further distribution to retail stores was made to SC, GA, FL, TN, VA, WV, KY, OH and PA.
 

Associated Products

Product DescriptionGilster-Mary Lee Corporation, Better Valu Fruit Whirls, Naturally Flavored packaged in a 28 oz (1 LB 12 OZ) (794g) plastic bag. (manufactured by Gilster Mary Lee, Joplin, MO)
Code InfoBag label: UPC 79801-24630 Best Buy Code: JUL 17 13 J8 Case label: UPC 79801-24632 Best Buy Code: JUL 17 13 JB
ClassificationClass I
Reason for RecallThe Better Valu Fruit Whirls contain undeclared almond butter.
Product Quantity102 cases/8/28-oz plastic bags
Recall NumberF-0722-2013

Class I Food Event

Event ID63503
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTorn & Glasser Inc.
CityEast Rancho Dominguez
StateCA
CountryUS
Distribution PatternUS states: CA, AZ, NV, TX, CO, ID, MO, NJ, NM, OK, UT. No international consignees.
 

Associated Products

Product DescriptionSalted in-shell Peanuts under the following. Salted in Shell PeanutsGless Ranch Label, Item Number 450-175, Pack Size 24/12 oz bags, UPC Code 72488980310. Salted in Shell PeanutsSun Harvest Label, Item Number 450-248, Pack Size 24/16 oz bags, UPC Code 646670306785. Salted in-shell Peanuts, Item Number 450-195, 50 lb Bulk Bag, UPC Code none. Salted in-shell PeanutsTorn and Glasser bulk case, Item Number 450-185, 25 lb Bulk Case, UPC Code none. Salted in-shell PeanutsTorn and Glasser retail label, Item Number 450-245, Pack Size 24/1 lb, UPC Code 72488858664. Salted in Shell PeanutsSprouts label, Item Number SP450-185, Pack Size 25 lb case/12bags, UPC Code 206561XXXXXX (last 6numbers change for each package -random weight).
Code InfoSalted in Shell Peanuts Gless Ranch Label. Lots: 0112; 0522; 0932. Lot code marking can be found on the front label. Salted in Shell Peanuts Sun Harvest Label. Best by Dates: 06/16/12; 05/09/12; 08/13/12; 07/08/12; 09/09/12; 10/22/12; 11/18/12; 11/26/12; 12/12/12; 02/05/13; 03/24/13; 03/30/13. Lot code marking can be found on the back corner next to the seal. Salted in-shell Peanuts. Bags marked with P.O. numbers: 34569; 35025; 35567; 35786; 36356; 36845; 37501; 38241; 38840. Lot code marking can be found on the white tag adhered to the bag. Salted in-shell Peanuts Torn and Glasser bulk case. Lots 0172; 0322; 0332; 0342; 0392; 0452; 0522; 0552; 0562; 0752; 0802; 0882; 0962; 1022; 1172;1232; 1302; 1312; 1422; 1562; 1652; 1802; 1882; 2052; 2142; 2352; 2402; 2482; 2631; 2772; 2851; 3141; 3151; 3201; 3231; 3271; 3331; 3341; 3531. Lot code marking can be found on the bottom of the box. Salted in-shell Peanuts Torn and Glasser retail label. Lots: 0872; 1382; 1572; 2082; 2202; 2422; 2502; 3221. Lot code marking can be found on the back corner next to the seal. Salted in Shell Peanuts Sprouts label. Best by dates: 03/11/12; 03/17/12; 03/18/12; 03/25/12; 03/30/12; 04/26/12; 05/12/12; 05/18/12;06/03/12; 06/06/12; 06/08/12; 06/13/12; 06/16/12; 06/21/12; 06/22/12; 06/30/12; 08/10/12; 09/06/12; 09/14/12; 10/28/12; 10/31/12; 11/10/12; 11/15/12; 11/17/12; 11/23/12; 12/05/12; 12/19/12; 01/05/13; 02/02/13. Lot code marking can be found on the front label.
ClassificationClass I
Reason for RecallTorn and Glasser, Inc of Los Angeles, CA 90021 is voluntarily recalling Salted in-shell product (packaged after November 9, 2011), and one lot of Organic Peanut Butter (packaged January 13, 2012) because they contain recalled peanuts and peanut butter received from Sunland, Inc., and have the potential to be contaminated with Salmonella,
Product Quantity9803 units
Recall NumberF-0707-2013
Product DescriptionOrganic Peanut Butter, Item Number 342-007, Pack size 12/14oz tubs. No UPC code. Product labeling:" ".
Code InfoLot 0132 (produced January 13, 2012). Lot code marking can be found on the side label.
ClassificationClass I
Reason for RecallTorn and Glasser, Inc of Los Angeles, CA 90021 is voluntarily recalling Salted in-shell product (packaged after November 9, 2011), and one lot of Organic Peanut Butter (packaged January 13, 2012) because they contain recalled peanuts and peanut butter received from Sunland, Inc., and have the potential to be contaminated with Salmonella,
Product Quantity191 units
Recall NumberF-0708-2013

Class I Food Event

Event ID63611
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmE.D. Produce
CityLos Angeles
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionGrape Tomatoes, 199 cartons x 12 packages x 1 pint.
Code InfoLot#1201015031
ClassificationClass I
Reason for RecallEd Produce is recalling grape tomatoes because they may be contaminated with Salmonella.
Product Quantity2388 units
Recall NumberF-0723-2013

Class II Biologics Event

Event ID41383
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Washed
Code Info11LT03850- Part 1; 11LT03850- Part 2
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications for release, were distributed.
Product Quantity2 units
Recall NumberB-0358-13

Class II Devices Event

Event ID52634
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jan-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNuVasive Inc
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
 

Associated Products

Product DescriptionScrew Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2069, JK2085, JK2102, JK2188, JK2171
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0348-2013
Product Description5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2053
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0349-2013
Product Description5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2051, JK2154
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0350-2013
Product Description5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2042, JK2080, JK2151
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0351-2013
Product Description5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2058, JK2054, JK2081, JK2143
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0352-2013
Product Description5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2082, JK2095, JK2165
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0353-2013
Product Description5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2059, JK2084, JK2148
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0354-2013
Product Description6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2057, JK2157.
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0355-2013
Product Description6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2083, JK2184
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0356-2013
Product Description6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2052, JK2070, JK2098, JK2160, JK2093, JK2159
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0357-2013
Product Description6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2071, JK2169, JK2167.
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0358-2013
Product Description6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2039, JK2072, JK2168.
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0359-2013
Product Description6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2060, JK2046, JK2180, JK2202, JK2213, JK2230, JK2231, JK2247, JK2244
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0360-2013
Product Description7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2094, JK2096
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0361-2013
Product Description7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2097, JK2190
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0362-2013
Product Description7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2098, JK2187
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0363-2013
Product Description7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2099, JK2186
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0364-2013
Product Description7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2056, JK2100, JK2162
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0365-2013
Product Description7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2101, JK2163
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0366-2013
Product DescriptionScrew Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK1949, JK2068, JK2071, JK2078, JK2079, JK2170, JK2206, JK2375, JK2387, JK2398, JK2400
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0367-2013
Product Description4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2035, JK2131, JK2349
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0368-2013
Product Description4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2036, JK2132, JK2350.
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0369-2013
Product Description5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2037, JK2130, JK2037, JK2366
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0370-2013
Product Description5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2043, JK2134, JK2364, JK2367
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0371-2013
Product Description5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2044, JK2144, JK2378, JK2144
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0372-2013
Product Description6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2055, JK2142, JK2172, JK2174, JK2192, JK2212, JK2173.
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0373-2013
Product Description6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2045, JK2038, JK2140, JK2361, JK2362, JK2365, JK2368, JK2370, JK2369, JK2377, JK2379
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0374-2013
Product Description6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: 2008400621, JK2039, JK2141, JK2191, JK2177, JK2178, JK2179, JK2181, JK2182, JK2183, JK2141, JK2181
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0375-2013
Product Description7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2040, JK2147, JK2381, JK2141
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0376-2013
Product Description7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2047, JK2152, JK2383, JK2394
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0377-2013
Product Description7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code InfoBatch: JK2041, JK2146, JK2396, JK2397
ClassificationClass II
Reason for RecallThe tulip portion of the screw assembly can disengage from the shank after implantation.
Product Quantity240 units total
Recall NumberZ-0378-2013

Class II Biologics Event

Event ID56198
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-May-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCSL Plasma, Inc.
CitySan Antonio
StateTX
CountryUS
Distribution PatternNC, IN
 

Associated Products

Product DescriptionSource Plasma
Code Info706368653; 8910006160; 8910005703; 891004620; 891003971; 8910003354; 8910002601; 8910001907; 8910001428; 8910000658; 8910000058; 7060239477; 7060238870; 7060235693; 7060235343; 7060233737; 7060232841; 7060232527; 7060230676; 7060230508; 7060229117; 7060228623; 7060227644; 7060227269; 7060226330; 7060225860; 7060224951; 7060224579; 7060223952; 7060223407; 7060222382; 7060221936; 7060213791; 7060213434; 7060211929; 7060211221; 7060210664; 7060209842; 7060209180; 7060208408; 7060207256; 7060206774; 7060205914; 7060205391; 7060368156
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability was not adequately determined, were distributed.
Product Quantity45 units
Recall NumberB-0356-13

Class II Drugs Event

Event ID62461
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmChurch & Dwight Inc
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionOrajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.
Code InfoLot #: BI1041, Exp 02/13
ClassificationClass II
Reason for RecallCGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Product Quantity42,768 pumps
Recall NumberD-061-2013

Class II Devices Event

Event ID62805
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKCI USA, Inc.
CitySan Antonio
StateTX
CountryUS
Distribution PatternNationwide Distribution including AL, CA, CO, OK and GA.
 

Associated Products

Product DescriptionRotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
Code InfoModel Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.
ClassificationClass II
Reason for RecallThe firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
Product Quantity282 units
Recall NumberZ-0409-2013

Class II Devices Event

Event ID62834
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Orthobiologics, Inc.
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV
 

Associated Products

Product DescriptionStyker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
Code InfoPart number 2113-0013, lot numbers T1203002, T1204005, and T1206001.
ClassificationClass II
Reason for RecallWhen preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. This small amount of blood (approximately 0.2 mL) would then migrate to the bottom of the centrifuge cup after the 2 minute centrifuge spin cycle.
Product Quantity3,268
Recall NumberZ-0431-2013

Class II Devices Event

Event ID62835
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternUSA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.
 

Associated Products

Product DescriptionDimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
Code InfoLots 12135AE and 12171BB
ClassificationClass II
Reason for RecallFirm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.
Product Quantity959 cartons
Recall NumberZ-0408-2013

Class II Devices Event

Event ID62916
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Apr-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmExtremity Medical LLC
CityParsippany
StateNJ
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland.
 

Associated Products

Product DescriptionIO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Code InfoProduct coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-30018:107511; 118-30020:107512; 118-30020:107513; 118-30022:107514; 118-30024:107515; 118-30026:107516; 118-40020:107457; 118-40025:107458; 118-40030;107529; 118-40030;107459; 118-40035:107460; 118-40040:107461; 118-40045:107462; 118-40050:107463; 118-40320:107613; 118-40325:107614; 118-40330:107615; 118-40330:107616; 118-40335:107617; 118-40340:107618; 118-40345:107619; 118-40350:107620.
ClassificationClass II
Reason for RecallProduct Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Product Quantity120 Units
Recall NumberZ-0344-2013

Class II Devices Event

Event ID63066
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
 

Associated Products

Product DescriptionProduct 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity128,946 all lots, all sizes
Recall NumberZ-0389-2013
Product Description00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity128,946 all lots, all sizes
Recall NumberZ-0390-2013
Product Description. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity128,946 all lots, all sizes
Recall NumberZ-0391-2013
Product Description00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity128,946 all lots, all sizes
Recall NumberZ-0392-2013
Product Description. 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity128,946 all lots, all sizes
Recall NumberZ-0393-2013
Product Description00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity128,946 all lots, all sizes
Recall NumberZ-0394-2013
Product Description00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity56,516 all lots, all sizes
Recall NumberZ-0395-2013
Product Description00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity56,516 all lots, all sizes
Recall NumberZ-0396-2013
Product Description00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity56,516 all lots, all sizes
Recall NumberZ-0397-2013
Product Description00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity56,516 all lots, all sizes
Recall NumberZ-0398-2013
Product Description00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity56,516 all lots, all sizes
Recall NumberZ-0399-2013
Product Description00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallZimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.
Product Quantity56,516 all lots, all sizes
Recall NumberZ-0400-2013

Class II Devices Event

Event ID63075
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternUS Nationwide including the states of: MA and TX.
 

Associated Products

Product DescriptionS-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
Code InfoLot Numbers: 012064-001
ClassificationClass II
Reason for RecallWhen using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides past the disc space as this could result in the possible misplacement of the implant and/or possible harm to the patient."
Product Quantity19 units
Recall NumberZ-0417-2013

Class II Devices Event

Event ID63077
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLinvatec Corp. dba ConMed Linvatec
CityLargo
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
 

Associated Products

Product Description"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Code InfoS8580 (8.0MM Drill Bit), lot numbers 322225 and 322226
ClassificationClass II
Reason for RecallLinvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.
Product Quantity70 total
Recall NumberZ-0383-2013
Product Description"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Code InfoS8585 (8.5MM Drill Bit), lot number 322287
ClassificationClass II
Reason for RecallLinvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.
Product Quantity70 total
Recall NumberZ-0384-2013

Class II Devices Event

Event ID63122
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - USA nationwide including the states of: AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Korea.
 

Associated Products

Product DescriptionMultipolar® Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar® Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00
Code InfoItem 00-5001-040- 22; Lot 61261192, 61261194, 61296091,
ClassificationClass II
Reason for RecallZimmer Inc. is initiating a removal of the Multipolar® Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
Product Quantity195
Recall NumberZ-0410-2013

Class II Devices Event

Event ID63126
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternUSA (nationwide) including the states of Ohio, Carolinas and New England.
 

Associated Products

Product DescriptionTrilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Code InfoItem 00-6334-062-36, Lot 62023769
ClassificationClass II
Reason for RecallTrilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
Product Quantity1
Recall NumberZ-0386-2013

Class II Devices Event

Event ID63144
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
 

Associated Products

Product DescriptionSpine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Code InfoLot Numbers: SFP02323, SFP02323R, and SFP02323RR
ClassificationClass II
Reason for RecallInspan Compressors may break at weld causing a loss of compression
Product Quantity17 units
Recall NumberZ-0412-2013

Class II Biologics Event

Event ID63173
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc.
CityLas Vegas
StateNV
CountryUS
Distribution PatternNV
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW042212029384G
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-0112-13

Class II Biologics Event

Event ID63195
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals LLC
CityGallup
StateNM
CountryUS
Distribution PatternUnited Kingdom
 

Associated Products

Product DescriptionSource Plasma
Code InfoGA1468179; GA1468692; GA1469352;
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving post- donations information, were distributed.
Product Quantity3 units
Recall NumberB-0116-13

Class II Biologics Event

Event ID63220
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternNJ
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW141611418327
ClassificationClass II
Reason for RecallBlood product, collected from a therapeutic donor and not labeled to indicate the type of donation, was distributed.
Product Quantity1 unit
Recall NumberB-0121-13

Class II Biologics Event

Event ID63236
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmStanford Medical School Blood Center
CityPalo Alto
StateCA
CountryUS
Distribution PatternCA and IN
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW070511610907; W070511714151
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity2 units
Recall NumberB-0118-13

Class II Biologics Event

Event ID63237
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems Inc
CityScottsdale
StateAZ
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW041012095914Y
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-0117-13

Class II Biologics Event

Event ID63239
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW142812407280U
ClassificationClass II
Reason for RecallBlood product, collected from a donor who may be at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-0109-13

Class II Biologics Event

Event ID63249
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternWI, NY, MN
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW051512093782 (part A); W051512093782 (part B); W051512093782 (part C)
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity3 units
Recall NumberB-0111-13

Class II Biologics Event

Event ID63261
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc
CityMcallen
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW041112038759Q
ClassificationClass II
Reason for RecallBlood product, left in shipping container and was exposed to unacceptable temperatures, was distributed.
Product Quantity1 unit
Recall NumberB-0120-13

Class II Biologics Event

Event ID63331
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInland Northwest Blood Center
CitySpokane
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW068512006765I;
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications for release, was distributed.
Product Quantity1 unit
Recall NumberB-0195-13

Class II Devices Event

Event ID63358
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK.
 

Associated Products

Product DescriptionStryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
Code InfoCatalog No: 2030-6525-1 Lot Code: MLHYL7, MLJT50 Ref 2030-6525-1
ClassificationClass II
Reason for RecallStryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.
Product QuantityApproximately 72 units
Recall NumberZ-0387-2013
Product DescriptionStryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
Code InfoCatalog No: 2030-6535-1 Lot Code: MLDNAV, MLDXV2, MLH11M, MLH17R, MLH3K8, MLH4L6, MLH7RV, MLHK1X, MLHL99, MLJDJT Ref 2030-6535-1
ClassificationClass II
Reason for RecallStryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.
Product QuantityApproximately 358 units
Recall NumberZ-0388-2013

Class II Devices Event

Event ID63386
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Spine
CityAllendale
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
 

Associated Products

Product DescriptionStryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.
Code InfoClass I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655
ClassificationClass II
Reason for RecallMultiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Product Quantity54
Recall NumberZ-0380-2013
Product DescriptionStryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.
Code InfoClass I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400
ClassificationClass II
Reason for RecallMultiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Product Quantity19 units
Recall NumberZ-0381-2013
Product DescriptionSPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.
Code InfoClass I device, 510(K) exempt Catalog Number: IS2217XLP Lot Number: 2576, 2756
ClassificationClass II
Reason for RecallMultiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Product Quantity28 units
Recall NumberZ-0382-2013

Class II Devices Event

Event ID63467
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBiomerieux Inc
CityHazelwood
StateMO
CountryUS
Distribution PatternWorldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA. Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina, Brazil, Bulgaria, Burkina FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DIVOIRE, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UNITED STATES, URUGUAY, VENEZUELA, VIETNAM, PALESTINE, AND SERBIA.
 

Associated Products

Product DescriptionbioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity70 modules
Recall NumberZ-0299-2013
Product DescriptionbioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity375 modules
Recall NumberZ-0300-2013
Product DescriptionbioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity145 modules
Recall NumberZ-0301-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity1336 kits
Recall NumberZ-0302-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity860 kits
Recall NumberZ-0303-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity30 kits
Recall NumberZ-0304-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity250 kits
Recall NumberZ-0305-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity
Recall NumberZ-0306-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity163 kits
Recall NumberZ-0307-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity671 kits
Recall NumberZ-0308-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity620 kits
Recall NumberZ-0309-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity556 kits
Recall NumberZ-0310-2013
Product DescriptionbioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity205 kits
Recall NumberZ-0311-2013
Product DescriptionbioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity205 kits
Recall NumberZ-0312-2013
Product DescriptionbioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity250 kits
Recall NumberZ-0313-2013
Product DescriptionbioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity29 kits
Recall NumberZ-0314-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity28 kits
Recall NumberZ-0315-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity12 kits
Recall NumberZ-0316-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity69 kits
Recall NumberZ-0317-2013
Product DescriptionbioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity2 modules
Recall NumberZ-0318-2013
Product DescriptionbioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity26 Modules
Recall NumberZ-0319-2013
Product DescriptionbioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity2 modules
Recall NumberZ-0320-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity288 kits
Recall NumberZ-0321-2013
Product DescriptionbioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity20 kits
Recall NumberZ-0322-2013
Product DescriptionbioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity12 kits
Recall NumberZ-0323-2013
Product DescriptionbioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity83 kits
Recall NumberZ-0324-2013
Product DescriptionbioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity22 kits
Recall NumberZ-0325-2013
Product DescriptionbioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity23 kits
Recall NumberZ-0326-2013
Product DescriptionbioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity10 kits
Recall NumberZ-0327-2013
Product DescriptionbioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity33 kits
Recall NumberZ-0328-2013
Product DescriptionbioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Code InfoIdentified by B.40 firmware
ClassificationClass II
Reason for RecallThe product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Product Quantity5 kits
Recall NumberZ-0329-2013

Class II Devices Event

Event ID63479
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomerieux Inc
CityHazelwood
StateMO
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) including the states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA and WI. Distribution was also made to Canada, military facilities and other foriegn countries.
 

Associated Products

Product Description0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use 0.45%-0.50% sodium chloride concentration only.
Code InfoLot number C866715, EXP OCT 13
ClassificationClass II
Reason for RecallThe firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.
Product Quantity199 cases/14-1000mL bags
Recall NumberZ-0430-2013

Class II Devices Event

Event ID63481
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVital Signs Devices, a GE Healthcare Company
CityTotowa
StateNJ
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states: AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada.
 

Associated Products

Product DescriptionCorometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
Code InfoLot #S03123 Model #7000AA0
ClassificationClass II
Reason for RecallThirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
Product Quantity126 cases (50 pouches per case)
Recall NumberZ-0330-2013

Class II Food Event

Event ID63482
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmThe Dannon Company Inc
CityMinster
StateOH
CountryUS
Distribution Pattern21 US states and Puerto Rico
 

Associated Products

Product DescriptionDannon Activia LIGHT Nonfat Yogurt Peach Flavor, Each unit 4-pack of 4-oz cups/6, 4-count pack to a case (24 cups/case) UPC 3663202633
Code InfoExpiration Code NOV 07 2012 MZ, Expiration Code NOV 09 2012 MZ, Expiration Code NOV 10 2012 MZ
ClassificationClass II
Reason for RecallNot labeled correctly
Product Quantity19,915 cases
Recall NumberF-0704-2013

Class II Devices Event

Event ID63500
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInnovative Magnetic Resonance Imaging Systems Inc.
CityWinnipeg
StateMB
CountryCA
Distribution PatternNationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
 

Associated Products

Product DescriptionIMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Code Info10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513
ClassificationClass II
Reason for RecallIMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
Product Quantity23
Recall NumberZ-0428-2013

Class II Devices Event

Event ID63504
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpacelabs Healthcare, Llc
CityIssaquah
StateWA
CountryUS
Distribution PatternWorldwide Distribution.
 

Associated Products

Product Descriptionqube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
Code InfoSerial numbers for devices distributed in the US: 1390-000102, 1390-000103, 1390-000104, 1390-000105, 1390-000106, 1390-000107, 1390-000108, 1390-000109, 1390-000110, 1390-000111, 1390-000112, 1390-000113, 1390-000114, 1390-000115, 1390-000116, 1390-000119, 1390-000120, 1390-000150, 1390-000151, 1390-000152, 1390-000153, 1390-000154, 1390-000155, 1390-000156, 1390-000157, 1390-000158, 1390-000159, 1390-000160, 1390-000161, 1390-000162, 1390-000163, 1390-000164, 1390-000165, 1390-000166, 1390-000167, 1390-000168, 1390-000169, 1390-000170, 1390-000171, 1390-000172, 1390-000173, 1390-000174, 1390-000175, 1390-000176, 1390-000177, 1390-000178, 1390-000179, 1390-000180, 1390-000181, 1390-000182, 1390-000183, 1390-000184, 1390-000185, 1390-000186, 1390-000187, 1390-000188, 1390-000189, 1390-000190, 1390-000191, 1390-000192, 1390-000193, 1390-000195, 1390-000196, 1390-000197, 1390-000198, 1390-000199, 1390-000200, 1390-000201, 1390-000202, 1390-000203, 1390-000204, 1390-000205, 1390-000206, 1390-000207, 1390-000208, 1390-000209, 1390-000210, 1390-000211, 1390-000212, 1390-000213, 1390-000214, 1390-000215, 1390-000216, 1390-000217, 1390-000218, 1390-000219, 1390-000220, 1390-000221, 1390-000222, 1390-000223, 1390-000224, 1390-000225, 1390-000226, 1390-000227, 1390-000228, 1390-000229, 1390-000230, 1390-000231, 1390-000232, 1390-000233, 1390-000234, 1390-000235, 1390-000236, 1390-000237, 1390-000238, 1390-000239, 1390-000240, 1390-000241, 1390-000242, 1390-000243, 1390-000244, 1390-000245, 1390-000246, 1390-000247, 1390-000248, 1390-000249, 1390-000250, 1390-000251, 1390-000252, 1390-000253, 1390-000254, 1390-000255, 1390-000256, 1390-000257, 1390-000258, 1390-000259, 1390-000260, 1390-000261, 1390-000262, 1390-000263, 1390-000264, 1390-000266, 1390-000267, 1390-000268, 1390-000269, 1390-000270, 1390-000271, 1390-000272, 1390-000273, 1390-000274, 1390-000275, 1390-000276, 1390-000277, 1390-000278, 1390-000279, 1390-000280, 1390-000281, 1390-000282, 1390-000283, 1390-000284, 1390-000285, 1390-000286, 1390-000287, 1390-000288, 1390-000289, 1390-000296, 1390-000297, 1390-000298, 1390-000299, 1390-000300, 1390-000301, 1390-000302, 1390-000304, 1390-000305, 1390-000307, 1390-000308, 1390-000310, 1390-000311, 1390-000312, 1390-000314, 1390-000315, 1390-000316, 1390-000317, 1390-000318, 1390-000319, 1390-000321, 1390-000322, 1390-000323, 1390-000325, 1390-000341, 1390-000342, 1390-000343, 1390-000344, 1390-000345, 1390-000346, 1390-000347, 1390-000348, 1390-000349, 1390-000350, 1390-000351, 1390-000352, 1390-000353, 1390-000354, 1390-000355, 1390-000356, 1390-000357, 1390-000358, 1390-000359, 1390-000360, 1390-000361, 1390-000362, 1390-000363, 1390-000364, 1390-000365, 1390-000366, 1390-000367, 1390-000368, 1390-000369, 1390-000370, 1390-000371, 1390-000372, 1390-000373, 1390-000374, 1390-000375, 1390-000376, 1390-000377, 1390-000378, 1390-000379, 1390-000380, 1390-000381, 1390-000382, 1390-000383, 1390-000384, 1390-000385, 1390-000386, 1390-000387, 1390-000388, 1390-000389, 1390-000390, 1390-000391, 1390-000392, 1390-000393, 1390-000394, 1390-000420, 1390-000421, 1390-000422, 1390-000423, 1390-000424, 1390-000425, 1390-000426, 1390-000427, 1390-000428, 1390-000429, 1390-000430, 1390-000431, 1390-000432, 1390-000433, 1390-000434, 1390-000435, 1390-000436, 1390-000437, 1390-000438, 1390-000439, 1390-000440, 1390-000441, 1390-000442, 1390-000443, 1390-000444, 1390-000445, 1390-000446, 1390-000447, 1390-000448, 1390-000449, 1390-000450, 1390-000451, 1390-000452, 1390-000453, 1390-000454, 1390-000455, 1390-000456, 1390-000457, 1390-000458, 1390-000459, 1390-000460, 1390-000461, 1390-000462, 1390-000463, 1390-000464, 1390-000465, 1390-000467, 1390-000468, 1390-000469, 1390-000470, 1390-000483, 1390-000564, 1390-000582, 1390-000583, 1390-000584, 1390-000585, 1390-000586, 1390-000587, 1390-000588, 1390-000589, 1390-000590, 1390-000591, 1390-000592, 1390-000593, 1390-000594, 1390-000595, 1390-000597, 1390-000598, 1390-000599, 1390-000600, 1390-000601, 1390-000602, 1390-000603, 1390-000606, 1390-000614, 1390-000615, 1390-000616, 1390-000623, 1390-000624, 1390-000625, 1390-000626, 1390-000627, 1390-000628, 1390-000629, 1390-000630, 1390-000631, 1390-000632, 1390-000633, 1390-000634, 1390-000635, 1390-000636, 1390-000637, 1390-000638, 1390-000639, 1390-000640, 1390-000641, 1390-000642, 1390-000643, 1390-000644, 1390-000645, 1390-000646, 1390-000647, 1390-000648, 1390-000649, 1390-000650, 1390-000651, 1390-000652, 1390-000653, 1390-000654, 1390-000655, 1390-000656, 1390-000657, 1390-000658, 1390-000659, 1390-000660, 1390-000661, 1390-000662, 1390-000663, 1390-000664, 1390-000665, 1390-000666, 1390-000667, 1390-000668, 1390-000669, 1390-000670, 1390-000671, 1390-000672, 1390-000673, 1390-000674, 1390-000675, 1390-000676, 1390-000677, 1390-000678, 1390-000679, 1390-000680, 1390-000681, 1390-000682, 1390-000683, 1390-000684, 1390-000685, 1390-000686, 1390-000687, 1390-000688, 1390-000698, 1390-000699, 1390-000700, 1390-000701, 1390-000702, 1390-000703, 1390-000704, 1390-000705, 1390-000706, 1390-000707, 1390-000708, 1390-000710, 1390-000712, 1390-000713, 1390-000714, 1390-000720, 1390-000721, 1390-000728, 1390-000729, 1390-000730, 1390-000731, 1390-000732, 1390-000733, 1390-000734, 1390-000735, 1390-000736, 1390-000737, 1390-000738, 1390-000742, 1390-000743, 1390-000744, 1390-000745, 1390-000746, 1390-000747, 1390-000748, 1390-000749, 1390-000750, 1390-000751, 1390-000752, 1390-000753, 1390-000754, 1390-000755, 1390-000756, 1390-000757, 1390-000758, 1390-000759, 1390-000760, 1390-000761, 1390-000762, 1390-000763, 1390-000764, 1390-000765, 1390-000766, 1390-000767, 1390-000768, 1390-000769, 1390-000775, 1390-000776, 1390-000777, 1390-000778, 1390-000779, 1390-000780, 1390-000781, 1390-000782, 1390-000792, 1390-000793, 1390-000794, 1390-000795, 1390-000796, 1390-000800, 1390-000801, 1390-000802, 1390-000803, 1390-000804, 1390-000805, 1390-000806, 1390-000807, 1390-000808, 1390-000809, 1390-000810, 1390-000811, 1390-000812, 1390-000813, 1390-000814, 1390-000815, 1390-000816, 1390-000817, 1390-000818, 1390-000819, 1390-000820, 1390-000821, 1390-000822, 1390-000823, 1390-000824, 1390-000825, 1390-000826, 1390-000827, 1390-000828, 1390-000829, 1390-000830, 1390-000831, 1390-000832, 1390-000833, 1390-000834, 1390-000835, 1390-000836, 1390-000837, 1390-000838, 1390-000839, 1390-000840, 1390-000841, 1390-000842, 1390-000843, 1390-000844, 1390-000845, 1390-000846, 1390-000847, 1390-000848, 1390-000849, 1390-000850, 1390-000851, 1390-000852, 1390-000853, 1390-000854, 1390-000855, 1390-000856, 1390-000857, 1390-000858, 1390-000859, 1390-000860, 1390-000861, 1390-000862, 1390-000863, 1390-000870, 1390-000871, 1390-000872, 1390-000887, 1390-000888, 1390-000889, 1390-000890, 1390-000891, 1390-000892, 1390-000893, 1390-000894, 1390-000895, 1390-000896, 1390-000897, 1390-000898, 1390-000899, 1390-000900, 1390-000901, 1390-000902, 1390-000903, and 1390-000904. Serial numbers for devices distributed INTERNATIONAL: 1390-000290, 1390-000291, 1390-000337, 1390-000338, 1390-000339, 1390-000340, 1390-000607, 1390-000608, 1390-000609, 1390-000610, 1390-000689, 1390-000690, 1390-000691, 1390-000692, 1390-000693, 1390-000695, 1390-000536, 1390-000537, 1390-000709, 1390-000722, 1390-000723, 1390-000724, 1390-000725, 1390-000879, 1390-000880, 1390-000881, 1390-000905, 1390-000906, 1390-000907, 1390-000908, 1390-000909, 1390-000910, , 1390-000009, 1390-000010, 1390-000011, 1390-000012, 1390-000013, 1390-000014, 1390-000015, 1390-000016, 1390-000017, 1390-000018, 1390-000046, 1390-000048, 1390-000049, 1390-000051, 1390-000052, 1390-000053, 1390-000056, 1390-000057, 1390-000059, 1390-000060, 1390-000061, 1390-000062, 1390-000063, 1390-000101, 1390-000117, 1390-000118, 1390-000125, 1390-000127, 1390-000128, 1390-000138, 1390-000139, 1390-000140, 1390-000141, 1390-000142, 1390-000143, 1390-000144, 1390-000145, 1390-000146, 1390-000147, 1390-000148, 1390-000149, 1390-000326, 1390-000327, 1390-000328, 1390-000329, 1390-000330, 1390-000331, 1390-000332, 1390-000333, 1390-000334, 1390-000335, 1390-000336, 1390-000466, 1390-000535, 1390-000552, 1390-000568, 1390-000605, 1390-000611, 1390-000612, 1390-000613, 1390-000715, 1390-000716, 1390-000739, 1390-000740, 1390-000741, 1390-000770, 1390-000787, 1390-000788, 1390-000789, 1390-000790, 1390-000791, 1390-000797, 1390-000798, 1390-000876, 1390-000877, 1390-000878, 1390-1390-000047, 1390-00002, 1390-000618, 1390-000619, 1390-000620, 1390-000621, 1390-000622, 1390-000509, 1390-000510, 1390-000511, 1390-000512, 1390-000513, 1390-000514, 1390-000553, 1390-000554, 1390-000121, 1390-000524, 1390-000771, 1390-000772, 1390-000292, 1390-000293, 1390-000294, 1390-000295, 1390-000911, 1390-000555, 1390-000556, 1390-000557, 1390-000558, 1390-000559, 1390-000560, 1390-000561, 1390-000562, 1390-000563, 1390-000565, 1390-000566, 1390-000567, 1390-000569, 1390-000570, 1390-000571, 1390-000572, 1390-000573, 1390-000574, 1390-000575, 1390-000576, 1390-000577, 1390-000578, 1390-000579, 1390-000580, 1390-000581, , 1390-000395, 1390-000396, 1390-000397, 1390-000398, 1390-000399, 1390-000400, 1390-000401, 1390-000402, 1390-000403, 1390-000404, 1390-000405, 1390-000406, 1390-000407, 1390-000408, 1390-000409, 1390-000410, 1390-000411, 1390-000412, 1390-000413, 1390-000414, 1390-000415, 1390-000416, 1390-000417, 1390-000418, 1390-000419, 1390-000604, 1390-000130, 1390-000131, 1390-000132, 1390-000133, 1390-000135, 1390-000136, 1390-000137, 1390-000493, 1390-000496, 1390-000497, 1390-000498, 1390-000499, 1390-000500, 1390-000501, 1390-000502, 1390-000525, 1390-000526, 1390-000527, 1390-000528, 1390-000529, 1390-000530, 1390-000531, 1390-000532, 1390-000533, 1390-000534, 1390-000596, 1390-000617, 1390-000799, and 1390-000696.
ClassificationClass II
Reason for RecallSpacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short.
Product Quantity742 total devices distributed; 530 with the U.S. and 212 Internationally.
Recall NumberZ-0403-2013

Class II Devices Event

Event ID63505
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT.
 

Associated Products

Product DescriptionUniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
Code InfoSerial Numbers: 600000 through 602389
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
Product Quantity1,756 units
Recall NumberZ-0345-2013
Product DescriptionUniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
Code InfoSerial Numbers: 900000 through 900491.
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
Product Quantity432 units
Recall NumberZ-0346-2013
Product DescriptionUniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
Code InfoSerial Numbers: Included in the corresponding Dxl system.
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
Product Quantity
Recall NumberZ-0347-2013

Class II Devices Event

Event ID63512
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Nov-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKerr Corporation
CityMiddleton
StateWI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
 

Associated Products

Product DescriptionFreedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.
Code InfoFreedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System has no expiration date. The affected units were produced and distributed since February 2011.
ClassificationClass II
Reason for RecallThe firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur.
Product Quantity1330 units
Recall NumberZ-0402-2013

Class II Devices Event

Event ID63516
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKerr Corporation
CityMiddleton
StateWI
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) and the countries of Canada and EU.
 

Associated Products

Product DescriptionThe brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.
Code InfoThe Laser Loupes are custom made-to-order products. There are no general model, catalog, code, lot or serial numbers. Laser Loupes have no expiration date. The affected units were produced and distributed since September 2008.
ClassificationClass II
Reason for RecallThe firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device.
Product Quantity639 units
Recall NumberZ-0414-2013

Class II Food Event

Event ID63517
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmCharter Baking Company
CityBoulder
StateCO
CountryUS
Distribution PatternNationally and global including Cuba and Puerto Rico.
 

Associated Products

Product DescriptionRudi's Organic Bakery, Colorado Cracked Wheat, 22 oz, UPC 031493-54373-6, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with white, black, green, maroon, and orange print writing.
Code InfoLot Code: 2-193-R.
ClassificationClass II
Reason for RecallRudi's Organic Bakery is voluntarily recalling select packages of Rudi's Organic Bakery bread loaves due to the possible presence of small metal objects.
Product Quantity4,704 loaves
Recall NumberF-0695-2013
Product DescriptionRudi's Organic Bakery, Multigrain Oat Bread, 22 oz, UPC 031493-82888-8, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with maroon, green, black, white, and orange print writing.
Code InfoLot Code: 1-173-R.
ClassificationClass II
Reason for RecallRudi's Organic Bakery is voluntarily recalling select packages of Rudi's Organic Bakery bread loaves due to the possible presence of small metal objects.
Product Quantity4,512 loaves
Recall NumberF-0696-2013
Product DescriptionRudi's Organic Bakery, Cinnamon Raisin, 24 oz, UPC 031493-92183-1, packed in flexible plastic bags. Labeling is tan, yellow, white, blue, maroon, and orange with white, black, green, maroon, and orange print writing.
Code InfoLot Code: 1-273-R.
ClassificationClass II
Reason for RecallRudi's Organic Bakery is voluntarily recalling select packages of Rudi's Organic Bakery bread loaves due to the possible presence of small metal objects.
Product Quantity5,710 loaves.
Recall NumberF-0697-2013

Class II Drugs Event

Event ID63524
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDr. Reddy's Laboratories, Inc.
CityBridgewater
StateNJ
CountryUS
Distribution PatternNationwide. No foreign consignees.
 

Associated Products

Product DescriptionDr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Code InfoLot C203090 Exp.03/14
ClassificationClass II
Reason for RecallFailed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Product Quantity1512 bottles
Recall NumberD-059-2013

Class II Devices Event

Event ID63532
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVital Signs Colorado Inc.
CityEnglewood
StateCO
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.
 

Associated Products

Product DescriptionVital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
Code InfoModel Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers: 12089A 12131A 5575A 5586X 5633U 5664E 5685G 5712T 12090B 12138A 5578K 5603R 5636Y 5666R 5685H 5714Z 12100A 12157B 5578L 5606U 5638P 5668N 5685J 12101B 12173A 5580Y 5614N 5638Q 5669G 5689Y 12102A 5573Q 5580Z 5615N 5648T 5669H 5691T 12108B 5574A 5581A 5621U 5648U 5671D 5692H 12109B 5574B 5581L 5623H 5653Z 5673V 5696Q 12114B 5574X 5583E 5631C 5658D 5683V 5700J 12117B 5574Y 5584C 5632V 5660C 5683W 5703N 12130B 5574Z 5584D 5633T 5664D 5683X 5708R
ClassificationClass II
Reason for RecallThere is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
Product Quantity243,685 units
Recall NumberZ-0407-2013

Class II Devices Event

Event ID63541
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK
 

Associated Products

Product DescriptionThe Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
Code InfoREF 6200-056-22, lot 62010615
ClassificationClass II
Reason for RecallZimmer Trilogy® Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
Product Quantity 24 USA; 71 worldwide
Recall NumberZ-0416-2013

Class II Drugs Event

Event ID63550
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Enterprises LLC dba Sterling Gelatin
CityPrince George
StateVA
CountryUS
Distribution PatternNJ
 

Associated Products

Product DescriptionLimed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA
Code InfoBatch No. SG4704, Exp 02/22/2017.
ClassificationClass II
Reason for RecallMicrobial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Product Quantity750 kgs
Recall NumberD-062-2013

Class II Devices Event

Event ID63554
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrthoPediatrics Corp
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
 

Associated Products

Product Description4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc® Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc® system. The PediLoc® Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc® Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure.
Code InfoPart number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only
ClassificationClass II
Reason for RecallComplaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
Product Quantity26
Recall NumberZ-0432-2013

Class II Devices Event

Event ID63557
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKerr Corporation
CityOrange
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
 

Associated Products

Product DescriptionBioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
Code InfoThe BioPlant part numbers and lot numbers affected by this recall are as follows: ÿProduct Description Part Numbers Lot Numbers SioPlant Curved Syringe, 0.125g 216110 All Production SioPlant Curved Syringe, 0.25g 216112 SioPlan! Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life BioPlant Curved Svrinoe, 0.250 216132 20k BioPlant Intro Pack 216112S
ClassificationClass II
Reason for RecallThe firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
Product Quantity22,410 units
Recall NumberZ-0401-2013

Class II Devices Event

Event ID63580
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmKing Systems Corp.
CityNoblesville
StateIN
CountryUS
Distribution PatternUS Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
 

Associated Products

Product DescriptionKING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD· Patient Size: 10-20kg Product Usage: Laryngeal airway
Code InfoREF: LAD-302, Lot #K120501
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0418-2013
Product DescriptionKING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD· Patient Size: 30-50kg Product Usage: Laryngeal airway
Code InfoREF: LAD-303, Lot #K120618
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0419-2013
Product DescriptionKING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD· Patient Size: 50-70kg
Code InfoREF: LAD-304, Lot #K120619
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0420-2013
Product DescriptionKING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD· Patient Size: >70kg Product Usage: Laryngeal airway
Code InfoREF: LAD-305, Lot #K120620 and Lot #K120406
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0421-2013
Product DescriptionKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD· Patient Size: 30-50kg Product Usage: Laryngeal airway
Code InfoREF: LAD-703, Lot #K120411
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0422-2013
Product DescriptionKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD· Patient Size: 50-70kg Product Usage: Laryngeal airway
Code InfoREF: LAD-704, Lot #K120412
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0423-2013
Product DescriptionKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD· Patient Size: >70kg Product Usage: Laryngeal airway
Code InfoREF: LAD-705, Lot #K120413
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0424-2013
Product DescriptionKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD· Patient Size: 10-20kg Product Usage: Laryngeal airway
Code InfoREF: LAD-902, Lot #K120414
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0425-2013
Product DescriptionKING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD· Patient Size: 30-50kg " Product Usage: Laryngeal airway
Code InfoREF: LAD-903, Lot #K120416
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0426-2013
Product DescriptionKING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD· Patient Size: 50-70kg " Product Usage: Laryngeal airway
Code InfoREF: LAD-904, Lot #K120417
ClassificationClass II
Reason for RecallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.
Product Quantity263 cases of product. (2,630 devices)
Recall NumberZ-0427-2013

Class II Devices Event

Event ID63581
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSuperstat Corp
CityRancho Dominguez
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.
 

Associated Products

Product DescriptionSuperstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot#P0616P, SSK15P
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0331-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot#R0117D, SSK03D.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0332-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot#R0315P, R0316P, R0317P, R1026P, S0703P, S1503P, SSK01P, SSM01P, SSN01P, SSN08P, SSN10P, SSN11P.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0333-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# R1018D, SSM02D, SSN12D .
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0334-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# R1018P, S1503P, S2802P, SSN03P .
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0335-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# SSC02, SSF02 .
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0336-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# SSF02, SSF03.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0337-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# SSG29, SSG47, SSG52, SSG54, SSG57, SSG60, SSG63, SSG65, SSG66.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0338-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# SSK02D, SSK05D.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0339-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# SSK07P.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0340-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# SSL01C, SSN04C.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0341-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# SSN02D.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units
Recall NumberZ-0342-2013
Product DescriptionSuperstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
Code InfoLot# SSN12D.
ClassificationClass II
Reason for RecallThe recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Product Quantity26,422 units total
Recall NumberZ-0343-2013

Class II Food Event

Event ID63588
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSchoep's Ice Cream Co, Inc
CityMadison
StateWI
CountryUS
Distribution Patternretail stores in KY, TN, and VA only
 

Associated Products

Product DescriptionTub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter Pecan ice cream
Code InfoBest if Used By 02/28/14
ClassificationClass II
Reason for RecallPackaging error. Toasted Butter Pecan ice cream was packaged in a container labeled as Vanilla Bean. However the lid on the package did state Toasted Butter Pecan.
Product Quantity4140 containers
Recall NumberF-0711-2013

Class II Devices Event

Event ID63596
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarl Zeiss Meditec, Inc.
CityDublin
StateCA
CountryUS
Distribution PatternNationwide Distribution including IL and MD
 

Associated Products

Product DescriptionINTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Code InfoPart number 304534-7500-000; lot number 540958.
ClassificationClass II
Reason for RecallA manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Product Quantity36 tootal, all lots
Recall NumberZ-0404-2013
Product DescriptionINTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Code InfoPart number 304534-7500-001; lot number 540959.
ClassificationClass II
Reason for RecallA manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Product Quantity36 total, all lots
Recall NumberZ-0405-2013
Product DescriptionINTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Code InfoPart number 304534-7500-002; lot number 540960.
ClassificationClass II
Reason for RecallA manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Product Quantity36 total, all lots
Recall NumberZ-0406-2013

Class II Devices Event

Event ID63597
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionGE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
Code Infopart number: 5421698
ClassificationClass II
Reason for RecallIt was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Product Quantity364 total units installed in US
Recall NumberZ-0197-2013
Product DescriptionGE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
Code Infopart numbers: 5555000-5, 5555000-6
ClassificationClass II
Reason for RecallIt was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Product Quantity364 total units installed in US
Recall NumberZ-0198-2013
Product DescriptionGE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
Code Infopart numbers: 5555000-3, 5555000-4
ClassificationClass II
Reason for RecallIt was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Product Quantity364 total units installed in US
Recall NumberZ-0199-2013
Product DescriptionGE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Code Infopart numbers:5555000, 5555000-2
ClassificationClass II
Reason for RecallIt was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Product Quantity364 total units installed in US
Recall NumberZ-0200-2013

Class II Devices Event

Event ID63607
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMako Surgical Corporation
CityPlantation
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA including IL, OR, IA, AZ, CA, CO, FL, MS, OK, PA, WV, NC, TX, NY, GA, NJ, OH, WA, VA, MA, MD, WI, MI, NV, MO, AL, UT, RI, AR, LA, ID, IN, and TN and Internationally to Japan, Scotland, Italy, Singapore, Turkey, Hong Kong, and Korea.
 

Associated Products

Product DescriptionThe RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
Code InfoROB S/N GUD S/N CAM S/N ROB036 GUD054 CAM054 ROB037 GUD043 CAM037 ROB038 GUD038 CAM038 ROB039 GUD039 CAM039 ROB040 GUD040 CAM035 ROB042 GUD042 CAM043 ROB046 GUD046 CAM046 ROB047 GUD044 CAM047 ROB048 GUD047 CAM048 ROB049 GUD048 CAM049 ROB051 GUD074 CAM074 ROB053 GUD053 CAM053 ROB054 GUD091 CAM091 ROB055 GUD055 CAM075 ROB056 GUD056 CAM066 ROB057 GUD058 CAM058 ROB059 GUD059 CAM059 ROB060 GUD060 CAM060 ROB061 GUD061 CAM061 ROB062 GUD063 CAM062 ROB063 GUD062 CAM063 ROB065 GUD065 CAM033 ROB066 GUD057 CAM057 ROB067 GUD067 CAM067 ROB069 GUD036 CAM036 ROB070 GUD070 CAM055 ROB071 GUD083 CAM083 ROB072 GUD072 CAM072 ROB074 GUD102 CAM102 ROB075 GUD103 CAM103 ROB076 GUD045 CAM045 ROB078 GUD082 CAM082 ROB079 GUD076 CAM076 ROB080 GUD071 CAM071 ROB081 GUD075 CAM070 ROB083 GUD069 CAM069 ROB084 GUD100 CAM100 ROB085 GUD079 CAM079 ROB086 GUD086 CAM086 ROB088 GUD088 CAM088 ROB089 GUD089 CAM089 ROB090 GUD080 CAM081 ROB091 GUD098 CAM098 ROB092 GUD051 CAM051 ROB093 GUD085 CAM085 ROB094 GUD094 CAM094 ROB095 GUD095 CAM095 ROB096 GUD125 CAM125 ROB097 GUD097 CAM097 ROB098 GUD093 CAM093 ROB099 GUD099 CAM099 ROB100 GUD081 CAM080 ROB101 GUD101 CAM101 ROB102 GUD077 CAM077 ROB103 GUD078 CAM078 ROB104 GUD104 CAM104 ROB106 GUD106 CAM106 ROB107 GUD107 CAM107 ROB108 GUD108 CAM108 ROB109 GUD109 CAM109 ROB110 GUD110 CAM110 ROB111 GUD111 CAM112 ROB112 GUD105 CAM111 ROB114 GUD113 CAM105 ROB116 GUD115 CAM116 ROB117 GUD116 CAM115 ROB118 GUD117 CAM117 ROB119 GUD118 CAM119 ROB120 GUD119 CAM118 ROB121 GUD120 CAM120 ROB122 GUD121 CAM121 ROB123 GUD122 CAM122 ROB124 GUD123 CAM123 ROB125 GUD124 CAM124 ROB126 GUD126 CAM126 ROB127 GUD127 CAM127 ROB129 GUD129 CAM129 ROB130 GUD130 CAM130 ROB131 GUD084 CAM084 ROB133 GUD133 CAM133 ROB134 GUD134 CAM134 ROB135 GUD135 CAM135 ROB136 GUD136 CAM136 ROB140 GUD140 CAM140 ROB141 GUD141 CAM141 ROB143 GUD143 CAM143 ROB145 GUD145 CAM145 ROB146 GUD146 CAM146 ROB147 GUD147 CAM147 ROB148 GUD148 CAM148 ROB149 GUD149 CAM149 ROB150 GUD150 CAM150 ROB151 GUD151 CAM151 ROB152 GUD152 CAM152 ROB153 GUD153 CAM153 ROB154 GUD154 CAM154 ROB155 GUD155 CAM155 ROB156 GUD156 CAM156 ROB158 GUD158 CAM158 ROB159 GUD159 CAM159 ROB160 GUD160 CAM160 ROB161 GUD161 CAM161 ROB163 GUD163 CAM163 ROB164 GUD164 CAM164 ROB165 GUD165 CAM165 ROB167 GUD167 CAM167 ROB170 GUD170 CAM170 ROB171 GUD131 CAM131 ROB172 GUD172 CAM172 ROB173 GUD173 CAM173 ROB175 GUD175 CAM175 ROB176 GUD176 CAM176 ROB177 GUD177 CAM177 ROB178 GUD178 CAM178 ROB180 GUD180 CAM180 ROB182 GUD182 CAM182 ROB183 GUD183 CAM183 ROB187 GUD187 CAM187 ROB191 GUD192 CAM191 ROB192 GUD193 CAM193 ROB193 GUD191 CAM192 ROB203 GUD203 CAM203 ROB204 GUD204 CAM204 ROB205 GUD205 CAM205 ROB206 GUD206 CAM206 ROB207 GUD207 CAM207 ROB050 GUD050 CAM050 ROB058 GUD066 CAM056 ROB073 GUD073 CAM073 ROB082 GUD037 CAM042 ROB137 GUD137 CAM137 ROB144 GUD144 CAM144 ROB168 GUD168 CAM168 ROB169 GUD169 CAM169 ROB181 GUD181 CAM181 ROB188 GUD188 CAM188
ClassificationClass II
Reason for RecallMAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.
Product Quantity137 devices
Recall NumberZ-0385-2013

Class II Devices Event

Event ID63613
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide Distribution including CA, IN, NC, OH, and UT.
 

Associated Products

Product DescriptionRanawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered
Code InfoPart 11-106054 Lot 528310
ClassificationClass II
Reason for RecallThe color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
Product Quantity16 (5 USA)
Recall NumberZ-0415-2013

Class II Devices Event

Event ID63618
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet 3i, LLC
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France.
 

Associated Products

Product DescriptionProduct is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Code InfoModel Number XIFNT413, Lot # 2012040462
ClassificationClass II
Reason for RecallBiomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
Product Quantity191 devices
Recall NumberZ-0297-2013
Product DescriptionProduct is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Code InfoModel Number IFOA411, Lot # 2011111333, 2011111333-S1
ClassificationClass II
Reason for RecallBiomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
Product Quantity76 devices
Recall NumberZ-0298-2013

Class II Drugs Event

Event ID63623
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRanbaxy Inc.
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionAtorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90
Code InfoLot #: 2407258, Exp 05/14
ClassificationClass II
Reason for RecallAdulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Product Quantity32,208 bottles
Recall NumberD-060-2013

Class II Devices Event

Event ID63629
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGyrus Acmi, Incorporated
CitySouthborough
StateMA
CountryUS
Distribution PatternWorldwide distribution: USA state of Kansas and country of Korea.
 

Associated Products

Product DescriptionPARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Code InfoJC470075
ClassificationClass II
Reason for RecallOne lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Product Quantity10 boxes/60 units
Recall NumberZ-0411-2013

Class II Devices Event

Event ID63631
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSentec AG
CityTherwil, Baselland
State
CountryCH
Distribution PatternDistributed only in MO.
 

Associated Products

Product DescriptionSenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.
Code InfoLot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D
ClassificationClass II
Reason for RecallA manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
Product Quantity195 boxes (9 per box)
Recall NumberZ-0433-2013
Product DescriptionSenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.
Code InfoLot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F
ClassificationClass II
Reason for RecallA manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
Product Quantity265 boxes (5 per box)
Recall NumberZ-0434-2013

Class II Devices Event

Event ID63633
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmCaptiva Spine, Inc
CityJupiter
StateFL
CountryUS
Distribution PatternNationwide Distribution (Distributed to one customer located in MN)
 

Associated Products

Product DescriptionCapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
Code InfoModel # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
ClassificationClass II
Reason for RecallCaptiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Product Quantity10
Recall NumberZ-0413-2013

Class II Food Event

Event ID63664
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCracker Industries, LLC
CityBradenton
StateFL
CountryUS
Distribution PatternShipped to one customer in FL
 

Associated Products

Product DescriptionBeagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended to be eaten raw as a condiment. Beagle Bay Organics, 4501 Manatee Ave W # 105, Bradenton, FL 34209
Code InfoLot # 1210871
ClassificationClass II
Reason for RecallCracker Industries, LLC dba Beagle Bay Organics recalled their Raw Sauerkraut, Kimchi due to a bolt that was found missing from the rotation mixer.
Product Quantity65 jars
Recall NumberF-0706-2013

Class III Biologics Event

Event ID41409
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionPlatelets
Code Info01KK17395
ClassificationClass III
Reason for RecallBlood product, manufactured from Whole Blood unit with an extended collection time, was distributed
Product Quantity1 unit
Recall NumberB-0355-13

Class III Biologics Event

Event ID58498
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Carolinas
CityCharlotte
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoF42212, F42011, F42013,F42665, F44512, F44519, F42347, F41185, F42146, F42057, F42592, F42913, F42602, F41718, F43037, F42673, F42663, F43013, F42502, F42200, F42410, F42144, F43012, F42912, F42054, F43082, F42889, F43233, F43501, F43509, F43651, F43657, F41186, F41187, F43678, F41897, F41944, F42206, F42209, F42210, F42213, F42214, F42219, F42222, F42227, F42228, F42252, F42355, F35840, F41695, F41698, F41699, F42122, F42127, F42128, F42129, F42391, F42394, F42400, F42407, F42010, F42015, F42018, F42019, F42023, F42024, F42033, F42034, F42035, F42036, F42038, F42045, F42050, F42243, F42244, F42245, F42247, F42248, F42250, F42270, F42413, F43005, F41712, F42136, F42137, F42139, F42140, F42142, F42145, F42149, F42150, F42276, F42277, F42281, F42503, F42505, F43014, F43019, F43021, F43024, F41715, F41716, F41722, F42305, F42307, F42521, F42907, F42917, F42922, F43028, F43029, F43030, F43033, F43048, F43049, F43056, F42066, F42348, F42601, F42603, F42607, F42709, F42749, F42998, F43070, F43073, F43078, F42664, F42667, F42668, F42672, F42674, F42675, F41179, F41181, F42754, F42756, F42888, F42891, F42893, F43231, F43234, F43236, F43240, F43244, F43278, F43291
ClassificationClass III
Reason for RecallBlood products, which were not manufactured in accordance to acceptable product specifications, were distributed.
Product Quantity147 units
Recall NumberB-0360-13

Class III Devices Event

Event ID62987
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMicrogenics Corporation
CityFremont
StateCA
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
 

Associated Products

Product DescriptionThermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .
Code InfoMAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014. MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.
ClassificationClass III
Reason for RecallIn house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Product Quantity2076 total in US , 596 total Foreign
Recall NumberZ-0379-2013

Class III Biologics Event

Event ID63179
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW038112119947
ClassificationClass III
Reason for RecallBlood product, which may have been exposed to unacceptable temperature during storage, was distributed.
Product Quantity1 unit
Recall NumberB-0113-13

Class III Biologics Event

Event ID63248
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBloodCenter of Wisconsin, Inc
CityMilwaukee
StateWI
CountryUS
Distribution PatternWI
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code InfoW036312921763; W036312921762; W036312922130; W036312922129; W036312922234; W036312922233; W036312922230; W036312922229; W036312922232; W036312922231
ClassificationClass III
Reason for RecallBlood products, not prepared according to specifications, were distributed.
Product Quantity10 units
Recall NumberB-0110-13

Class III Biologics Event

Event ID63330
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmArc Blood Services, New England Region
CityDedham
StateMA
CountryUS
Distribution PatternMassachusetts; New York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info004GJ51699; 004GJ51699; 004GJ51699; 004GJ51700; 004GJ51700;
ClassificationClass III
Reason for RecallBlood products, with incorrectly transcribed platelet counts, were distributed.
Product Quantity5 units
Recall NumberB-0191-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info004GJ51698; 004GJ51698; 004GJ51698; 04GZ09699; 004GZ09699;
ClassificationClass III
Reason for RecallBlood products, with incorrectly transcribed platelet counts, were distributed.
Product Quantity5 units
Recall NumberB-0192-13

Class III Devices Event

Event ID63539
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmHoriba Instruments, Inc dba Horiba Medical
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionMinotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagents
Code InfoModel Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).
ClassificationClass III
Reason for RecallHORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010.
Product Quantity22,954
Recall NumberZ-0429-2013

Class III Food Event

Event ID63547
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSwanson Health Products, Inc
CityFargo
StateND
CountryUS
Distribution PatternAll states except Vermont and Wyoming plus Washington, DC and Puerto Rico; Canada was the only other country.
 

Associated Products

Product DescriptionSwanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3.
Code Info1841231C, 1071206C
ClassificationClass III
Reason for RecallThis is to inform you of a product recall involving 2 lots of Swanson Organic 100% Certified Organic Fennel Seed (SWF092). Some jars of fennel seeds have been found to contain small, red beetle-type insects.
Product Quantity746 bottles
Recall NumberF-0705-2013

Mixed Classification Food Event

Event ID62629
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSartori Inspirations, LLC
CityLafayette
StateCO
CountryUS
Distribution PatternDistributed to Whole Foods Grocery chain only with nationwide locations including Rocky Mountain, Northeast, North Atlantic, Mid Atlantic, Northwest, and Southwest.
 

Associated Products

Product DescriptionKalamata Tapenade packaged in 7 oz clear plastic and 5 lb white plastic capacity containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number KX21921; KT21921.
ClassificationClass I
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity6 x 5 lb units and 35 x 7oz cases (420 units)
Recall NumberF-0712-2013
Product DescriptionMediterranean Tapenade packaged in 7 oz clear plastic and 5 lb capacity white plastic tubs, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number MT21911; MT21921.
ClassificationClass I
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity27 cases (324 units) - 7 oz; 18 x 5 lb units
Recall NumberF-0713-2013
Product DescriptionTex Mex Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number TM21931.
ClassificationClass I
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity13 cases(156 units)
Recall NumberF-0714-2013
Product DescriptionSmoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number SG21931.
ClassificationClass I
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity28 cases (336 units)
Recall NumberF-0715-2013
Product DescriptionPimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number PM21931.
ClassificationClass I
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity26 cases (312 units).
Recall NumberF-0716-2013
Product DescriptionJalapeno Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number JC21931.
ClassificationClass I
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity30 cases (360 units)
Recall NumberF-0717-2013
Product DescriptionMango Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number MS21991.
ClassificationClass II
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity2 cases (24 units).
Recall NumberF-0718-2013
Product DescriptionSpinach Feta Dip packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number FS21931.
ClassificationClass I
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity5 cases
Recall NumberF-0719-2013
Product DescriptionFamous Thick Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number FT21921.
ClassificationClass II
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity1 case (12 units)
Recall NumberF-0720-2013
Product DescriptionSalsa Cream Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Code InfoLot number SC21931.
ClassificationClass II
Reason for RecallSartori is recalling various dips, salsas, and cheese products which may have been manufactured onion mixes which were recalled by another firm due to possible contamination with Listeria monocytogenes.
Product Quantity2 cases (24 units)
Recall NumberF-0721-2013

Mixed Classification Food Event

Event ID61531
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPostres de Aqui, Inc.
CityCatano
StatePR
CountryUS
Distribution PatternPR Only.
 

Associated Products

Product Description"Titan Gelatinas***Postres de gelatina (Gelatin Dessert)***Sabor a China (Orange flavored)***Sabor a Fresa (Strawberry flavored)"
Code Infonone
ClassificationClass II
Reason for RecallUndeclared allergens (Yellow #5).
Product Quantity424 boxes (54 units each)
Recall NumberF-0709-2013
Product Description"***Avena de Aquí Si Azucar Añadida****8oz****Fabricado por Postres de Aqui, Inc. Calle B Parrio Plamas Cataño PR 00962***"
Code Infonone
ClassificationClass III
Reason for RecallLack of phenylketonurics warning.
Product Quantity2 boxes (32 units each)
Recall NumberF-0710-2013

Mixed Classification Biologics Event

Event ID63221
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternOH and IN
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW035412058570
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0114-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW035412058570
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0115-13
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