American Contract Systems, Inc. Recall 90574
Description: Various Angiography packs/trays
American Contract Systems, Inc. Recall 90574 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1689-2022 |
| Event ID | 90574 |
| Event Description | Various Angiography packs/trays |
| Product Type | Devices |
| Distribution | Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX |
| Quantity | 57 units |
| Recall Reason | Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| Device Classification | 20220914 |
| Device Code Info | Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number: 1) LSRARTDATANGA,2105051, 884211, 44136929 2) LSRANGIRM21G,2105111, 874211, 63991913 3) LSRCFHANGD,2106031, 854211, 14887381 4) LSRARTDATANGA,2107102, 821211, 44256256 5) LSRARTDATANGA,2107102, 821211, 44256255 6) LSRARTDATANGA,2110011, 742211, 44373255 7) LSRARTDATANGA,2110011, 742211, 44373260 8) LMAN19U,2106292, 824211, 64169682 9) IHAN02S,2108111, 782211, 64190032 10) ANCA80AG,2109161, 743211, 64222813 11) SLPC34,2104022, 908211, 44127417-005 12) MHHY51F,2104151, 895211, 63978560-006 13) CXAN39N,2105072, 873211, 14875221-004 14) FHAG11X,2105072, 873211, 44111418-005 15) MHIR99AF,2105132, 868211, 63958625-006 16) BHAN91L,2105211, 860211, 44107976-005 17) ANCA80AG,2105212, 860211, 63956879-006 18) UDIN23AB,2105253, 855211, 63955146-006 19) SLPC34H,2106011, 853211, 44130251-005 20) SLPC34H,2106232, 827211, 43995487-005 21) SLPC34H,2106232, 827211, 43995488-005 22) FHAG11X,2106252, 825211, 43993760-005 23) FHAG11X,2106252, 825211, 44247863-005 24) SLPC34H,2107082, 817211, 44245946-005 25) CXAN39N,2107261, 793211, 15007653-004 26) CXAN39N,2107261, 793211, 15007652-004 27) UDCO10A,2107292, 790211, 64109977-006 28) BHAN91L,2107302, 789211, 44235082-005 29) FHAG11X,2108102, 778211, 44240799-005 30) FHAG11X,2108102, 778211, 44240798-005 31) BHAN91,2108131, 776211, 44240114-005 32) SLPC34H,2108242, 764211, 44315271-005 33) SLPC34H,2108242, 764211, 44315270-005 34) BHAN91L,2109101, 748211, 44320300-005 35) FHAG11X,2109151, 742211, 44318761-005 36) SLPC34H,2109232, 734211, 44316981-005 37) NCAG62G,2105252, 860211, 64063801-006 38) TMAN84F,2106162, 838211, 64044558-006 39) TMAN84F,2106162, 838211, 64044569-006 40) GSAN26D,2108131, 778211, 44216057-005 41) GSAN26D,2108131, 778211, 44215917-005 42) CGSP34G,2108271, 764211, 44336891-005 43) CGSP34G,2108271, 764211, 44336906-005 44) CGSP34G,2108271, 764211, 44336889-005 45) CGSP34G,2108271, 764211, 44336890-005 46) GSAN26D,2109271, 735211, 44353838-005 47) GSAN26D,2109271, 735211, 44353837-005 48) GSAN26D,2109271, 735211, 44353836-005 49) SJAR31F,2104211, 894211, 14702002-004 50) SJMY36D,2105241, 859211, 14894016-004 51) WHAI40C,2106071, 844211, 64133103-006 52) SSAR20D,2106151, 838211, 14893801-004 53) SJAR31F,2107191, 805211, 15031953-004 54) MPRM25D,2107261, 797211, 15028609-004 55) SJAR31F,2108231, 769211, 15025673-004 56) SJAR31F,2109141, 743211, 15023697-004 57) WHAI40C,2109241, 735211, 64135103-006 |
| Center Classification Date | 20220908 |
| Recall Initiation Date | 20220616 |
| Recalling Firm | American Contract Systems, Inc. |
| Initial Notification | |
| Similar To |