American Contract Systems, Inc. Various Angiography packs/trays Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Various Angiography packs/trays
Brand
American Contract Systems, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
American Contract Systems, Inc. is recalling Various Angiography packs/trays due to Product was exposed to multiple sterilization cycles without validation for multiple exposures.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Recommended Action
Per FDA guidance
The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to angela.bunn@owens-minor.com as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026