{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205119", "product_res_number": "Z-0817-2024", "event_date_initiated": "2023-11-29", "event_date_posted": "2024-01-26", "recall_status": "Open, Classified", "res_event_number": "93656", "product_code": "OES", "product_description": "Custom procedural convenience kits and trays, cardiac, labeled as: \na) HEART CATHETERIZATION TRAY, kit number JRHC45G; \nb) TAVR PACK, kit number LLTV10; \nc) CATH PED LF SJH, kit number SJCA21F; \nd) CATH HEART ADL LF SJH, kit number SJCH22F; \ne) INT RAD PORTS-LF - 206060, kit number UDIR58AL", "code_info": "a) JRHC45G, UDI/DI 00191072164240, Lot Numbers: 912231, exp. 3/29/2024; 920231, exp. 3/21/2024; 952231, exp. 2/17/2024; 963231, exp. 2/6/2024; 976231, exp. 6/2/2023; 654221, exp. 12/12/2023; 714221, exp. 10/13/2023; 717221, exp. 6/7/2023; 766221, exp. 8/22/2023; 814221, exp. 7/5/2023; \n\nb) LLTV10, UDI/DI 00191072183255, Lot Numbers: 644221, exp. 12/22/2023; 973231, exp. 1/27/2024; 952231, exp. 2/17/2024; 924231, exp. 3/17/2024; \n\nc) SJCA21F, UDI/DI None, Lot Numbers: 666221, exp. 11/30/2023; 701221, exp. 10/26/2023; 747221, exp. 9/10/2023; 779221, exp. 8/9/2023; 807221, exp. 7/12/2023; 846221, exp. 6/3/2023; 919231, exp. 3/22/2024; 954231, exp. 2/15/2024; 988231, exp. 1/12/2024; \n\nd) SJCH22F, UDI/DI None, Lot Numbers: 670221, exp. 11/26/2023; 708221, exp. 10/19/2023; 747221, exp. 9/10/2023; 795221, exp. 7/24/2023; 834221, exp. 6/15/2023; 873221, exp. 5/7/2023; 937231, exp. 3/4/2024; 991231, exp. 1/9/2024; \n\ne) UDIR58AL, UDI/DI None, Lot Numbers: 682221, exp. 11/14/2023; 638221, exp. 7/31/2023; 963231, exp. 2/6/2024; 925231, exp. 3/16/2024; 883231, exp. 10/30/2023", "firm_fei_number": "3003309947", "recalling_firm": "American Contract Systems, Inc.", "address_1": "7802 E Telecom Pkwy", "city": "Temple Terrace", "state": "FL", "postal_code": "33637-0928", "additional_info_contact": "Marlene Jones \n470-280-4277", "reason_for_recall": "During an internal investigation, ACS identified that several components were \"piggybacked\" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the \"piggybacked\" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.", "root_cause_description": "Process control", "action": "Owens & Minor issued an URGENT: MEDICAL DEVICE CORRECTION notice to it consignees on 11/29/2023 via email. Then notice explained the problem, risk to health, and requested the following actions be taken:\nIf you received any of the batches/lots identified, please segregate and quarantine all affected product.\nAdd warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling.\n\" Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n\" Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this field correction and maintain records of effectiveness. \nReport any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.", "product_quantity": "4394 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "registration_number": [ "2029015", "3005595283", "9616088", "1016427", "3045816907", "3005012805", "1928237", "9616099", "3004519921", "1824619", "3011144486", "3035642068", "1423537", "3045816902", "1018470", "1061124", "3010532612", "3011137372", "3004911384", "3008513424", "3004122598", "1030451", "3007329020", "3004111573", "1423395", "9680794", "3009888344", "1047429", "1422634", "1643817", "3015173212" ], "fei_number": [ "3005595283", "1000514656", "1000512168", "1016427", "3045816907", "3005012805", "1928237", "1824619", "3011144486", "3035642068", "3045816902", "3003528016", "1018470", "3010532612", "3004911384", "3008513424", "3004122598", "3001236905", "3002902735", "3005747797", "1030451", "3007329020", "1000160458", "3004111573", "3005846326", "3000717925", "3009888344", "1047429", "1643817", "3003737899", "3015173212" ], "device_name": "Cardiac Catheterization Kit", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1200", "device_class": "2" } } ] }