Various Angiography packs/trays recall
Various Angiography packs/trays
Why was Various Angiography packs/trays recalled?
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Various Angiography packs/trays
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 57 units
- 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
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)