{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 17 } }, "results": [ { "cfres_id": "194860", "product_res_number": "Z-1689-2022", "event_date_initiated": "2022-06-16", "event_date_created": "2022-09-08", "recall_status": "Open, Classified", "res_event_number": "90574", "product_code": "OEQ", "product_description": "Various Angiography packs/trays", "code_info": "Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number:\n\n1) LSRARTDATANGA,2105051, 884211, 44136929\n2) LSRANGIRM21G,2105111, 874211, 63991913\n3) LSRCFHANGD,2106031, 854211, 14887381\n4) LSRARTDATANGA,2107102, 821211, 44256256\n5) LSRARTDATANGA,2107102, 821211, 44256255\n6) LSRARTDATANGA,2110011, 742211, 44373255\n7) LSRARTDATANGA,2110011, 742211, 44373260\n8) LMAN19U,2106292, 824211, 64169682\n9) IHAN02S,2108111, 782211, 64190032\n10) ANCA80AG,2109161, 743211, 64222813\n11) SLPC34,2104022, 908211, 44127417-005\n12) MHHY51F,2104151, 895211, 63978560-006\n13) CXAN39N,2105072, 873211, 14875221-004\n14) FHAG11X,2105072, 873211, 44111418-005\n15) MHIR99AF,2105132, 868211, 63958625-006\n16) BHAN91L,2105211, 860211, 44107976-005\n17) ANCA80AG,2105212, 860211, 63956879-006\n18) UDIN23AB,2105253, 855211, 63955146-006\n19) SLPC34H,2106011, 853211, 44130251-005\n20) SLPC34H,2106232, 827211, 43995487-005\n21) SLPC34H,2106232, 827211, 43995488-005\n22) FHAG11X,2106252, 825211, 43993760-005\n23) FHAG11X,2106252, 825211, 44247863-005\n24) SLPC34H,2107082, 817211, 44245946-005\n25) CXAN39N,2107261, 793211, 15007653-004\n26) CXAN39N,2107261, 793211, 15007652-004\n27) UDCO10A,2107292, 790211, 64109977-006\n28) BHAN91L,2107302, 789211, 44235082-005\n29) FHAG11X,2108102, 778211, 44240799-005\n30) FHAG11X,2108102, 778211, 44240798-005\n31) BHAN91,2108131, 776211, 44240114-005\n32) SLPC34H,2108242, 764211, 44315271-005\n33) SLPC34H,2108242, 764211, 44315270-005\n34) BHAN91L,2109101, 748211, 44320300-005\n35) FHAG11X,2109151, 742211, 44318761-005\n36) SLPC34H,2109232, 734211, 44316981-005\n37) NCAG62G,2105252, 860211, 64063801-006\n38) TMAN84F,2106162, 838211, 64044558-006\n39) TMAN84F,2106162, 838211, 64044569-006\n40) GSAN26D,2108131, 778211, 44216057-005\n41) GSAN26D,2108131, 778211, 44215917-005\n42) CGSP34G,2108271, 764211, 44336891-005\n43) CGSP34G,2108271, 764211, 44336906-005\n44) CGSP34G,2108271, 764211, 44336889-005\n45) CGSP34G,2108271, 764211, 44336890-005\n46) GSAN26D,2109271, 735211, 44353838-005\n47) GSAN26D,2109271, 735211, 44353837-005\n48) GSAN26D,2109271, 735211, 44353836-005\n49) SJAR31F,2104211, 894211, 14702002-004\n50) SJMY36D,2105241, 859211, 14894016-004\n51) WHAI40C,2106071, 844211, 64133103-006\n52) SSAR20D,2106151, 838211, 14893801-004\n53) SJAR31F,2107191, 805211, 15031953-004\n54) MPRM25D,2107261, 797211, 15028609-004\n55) SJAR31F,2108231, 769211, 15025673-004\n56) SJAR31F,2109141, 743211, 15023697-004\n57) WHAI40C,2109241, 735211, 64135103-006", "firm_fei_number": "3003419114", "recalling_firm": "American Contract Systems, Inc.", "address_1": "2610 Ne Industrial Dr Ste 220 2610 Ne Industrial Dr", "address_2": "Ste 220", "city": "Kansas City", "state": "MO", "postal_code": "64117-2648", "additional_info_contact": "816-920-5846", "reason_for_recall": "Product was exposed to multiple sterilization cycles without validation for multiple exposures.", "root_cause_description": "Process change control", "action": "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.\n\nCustomers 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.\n\nA 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.\n\nIf you have any questions, please call 816-920-5846.", "product_quantity": "57 units", "distribution_pattern": "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", "openfda": { "registration_number": [ "1928237", "1125782", "3002807314", "9616662", "3002834291", "1721676", "1030451", "1047429", "3012536737", "3005012805", "3009605245", "1061124", "3004911384", "1043214", "1423395", "2030624", "3015225571", "1721504", "3009888344", "1724474", "1018470", "3045816902", "3011642792", "1319639", "3045816907", "3005595283", "3004605321", "3015173212", "3015309643", "3008513424", "1123137", "2320762", "3007329020", "3004122598", "3014925393", "3035642068", "1422634", "2029015", "3007289408", "1643817", "1625425", "1054241", "3033589330", "1055236", "1423537", "9616088", "3007138831", "3015910259", "3004519921", "3004111573", "3012964172", "3006950086" ], "fei_number": [ "1928237", "1000123180", "3002807314", "3002834291", "1721676", "1030451", "1047429", "3012536737", "3005012805", "3003040625", "1000138054", "3009605245", "3002975287", "3004911384", "1043214", "1721504", "3015225571", "1000112877", "3003094851", "3009888344", "1018470", "3045816902", "3011642792", "3000717925", "3045816907", "3005595283", "1000514656", "3004605321", "3015173212", "3015309643", "1000112968", "3008513424", "1000160458", "3005846326", "3000335778", "3007329020", "3002902735", "3004122598", "3014925393", "3035642068", "3001236905", "3007289408", "1643817", "1625425", "3007138831", "3033589330", "3000206435", "3015910259", "3004111573", "3012964172", "1000512168", "3006950086" ], "device_name": "Angiography/Angioplasty Kit", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1650", "device_class": "2" } } ] }