{ "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": "205129", "product_res_number": "Z-0822-2024", "event_date_initiated": "2023-11-29", "event_date_posted": "2024-01-26", "recall_status": "Open, Classified", "res_event_number": "93656", "product_code": "FDE", "product_description": "Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: \na)\tLAP KIDNEY MODULE, kit number AGKD50L; \nb)\tROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; \nc)\tLAP CHOLE - 213388, kit number BFLC02AD; \nd)\tGENERAL LAPAROSCOPY PACK, kit number GUGE09I; \ne)\tLAP CHOLE PACK, kit number HNLC80I; \nf)\tLap Chole Ovarian Appy, kit number JSLC06I; \ng)\tLAP CHOLE, ST LUKES, kit number LMLP08Z; \nh)\tROBOTIC PACK - 242561, kit number MHRB88AJ; \ni)\tKIT, GENERAL LAPAROSCOPY, kit number MMLP40F; \nj)\tKIT, MAJOR LAPAROTOMY, kit number MMML26F; \nk)\tLAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K; \nl)\tGENERAL LAPAROSCOPY SAH, kit number SAGL57H; \nm)\tROBOTIC PACK SAH, kit number SARB30K; \nn)\tROBOTIC PACK SAH, kit number SARB30L; \no)\tROBOTIC PACK SAH, kit number SARB30M; \np)\tLAP CHOLE PACK, kit number SMLC53; \nq)\tROBOTICS PACK, kit number SNRP85D; \nr)\tROBOTIC PACK, kit number SSRO22C; \ns)\tROBOTIC PACK, kit number SSRO22D; \nt)\tTPK DAVINCI PROSTATE SYSTEM, kit number TPDV16; \nu)\tASC LAP CHOLE PACK (PS 42279), kit number UICH53Y; \nv)\tGENERAL LAPAROSCOPIC PACK, kit number WVGL60E", "code_info": "a)\tAGKD50L, UDI/DI 00191072141156, Lot Numbers: 905231, exp. 4/5/2024; 638221, exp. 12/28/2023; 689221, exp. 5/21/2023; \nb)\tANPR34S, UDI/DI 00191072171351, Lot Numbers: 721221, exp. 10/6/2023; 879231, exp. 5/1/2024; 896231, exp. 4/14/2024; 927231, exp. 3/14/2024; 956231, exp. 2/13/2024; 645221, exp. 12/21/2023; \nc)\tBFLC02AD, UDI/DI 00191072169075, Lot Numbers: 654221, exp. 12/12/2023; 647221, exp. 12/19/2023; 987231, exp. 1/13/2024; UDI/DI 00191072188830, Lot Numbers: 946231, exp. 2/23/2024; 896231, exp. 4/14/2024; \nd)\tGUGE09I, UDI/DI none, Lot Numbers: 768221, exp. 8/20/2023; \ne)\tHNLC80I, UDI/DI 00191072146267, Lot Numbers: 797221, exp. 7/22/2023; 679221, exp. 11/17/2023; 995231, exp. 1/25/2024; 911231, exp. 3/30/2024; \nf)\tJSLC06I, UDI/DI 00191072126061, Lot Numbers: 839221, exp. 6/10/2023; 766221, exp. 8/22/2023; \ng)\tLMLP08Z, UDI/DI none, Lot Numbers: 661221, exp. 12/5/2023; 987231, exp. 1/13/2024; 942231, exp. 2/27/2024; 893231, exp. 4/17/2024; \nh)\tMHRB88AJ, UDI/DI none, Lot Numbers: 735221, exp. 9/22/2023; 710221, exp. 10/17/2023; 997231, exp. 1/3/2024; 959231, exp. 2/10/2024; 904231, exp. 4/6/2024; \ni)\tMMLP40F, UDI/DI none, Lot Numbers: 933231, exp. 3/8/2024; 879231, exp. 5/1/2024; \nj)\tMMML26F, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 896231, exp. 4/14/2024; \nk)\tOWLC07K, UDI/DI none, Lot Numbers: 682221, exp. 11/14/2023; 646221, exp. 12/20/2023; 982231, exp. 1/18/2024; 928231, exp. 3/13/2024; \nl)\tSAGL57H, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 790221, exp. 7/29/2023; \nm)\tSARB30K, UDI/DI none, Lot Numbers: 845221, exp. 6/4/2023; 888221, exp. 4/22/2023; \nn)\tSARB30L, UDI/DI none, Lot Numbers: 752221, exp. 9/5/2023; \no)\tSARB30M, UDI/DI none, Lot Numbers: 658221, exp. 12/8/2023; 700221, exp. 10/27/2023; 792221, exp. 7/27/2023; 949231, exp. 2/20/2024; 983231, exp. 1/17/2024; \np)\tSMLC53, UDI/DI 00191072188465, Lot Numbers: 969231, exp. 1/31/2024; \nq)\tSNRP85D, UDI/DI none, Lot Numbers: 666221, exp. 11/30/2023; 720221, exp. 10/7/2023; 793221, exp. 7/26/2023; 853221, exp. 5/27/2023; 965231, exp. 2/4/2024; \nr)\tSSRO22C, UDI/DI none, Lot Numbers: 891221, exp. 04/19/2023; \ns)\tSSRO22D, UDI/DI none, Lot Numbers: 660221, exp. 5/31/2023; 698221, exp. 10/29/2023; 756221, exp. 9/1/2023; 804221, exp. 7/15/2023; 840221, exp. 6/9/2023; 933231, exp. 8/31/2023; 987231, exp. 1/13/2024; \nt)\tTPDV16, UDI/DI 00191072128904, Lot Numbers: 856221, exp. 5/24/2023; 744221, exp. 9/13/2023; 675221, exp. 11/21/2023; 932231, exp. 3/9/2024; \nu)\tUICH53Y, UDI/DI none, Lot Numbers: 897231, exp. 4/13/2024; 882231, exp. 4/28/2024; \nv)\tWVGL60E, UDI/DI 00191072144034, Lot Numbers: 766221, exp. 8/22/2023; 694221, exp. 11/2/2023; 952231, exp. 2/17/2024;", "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": "3196 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "device_name": "Laparoscopy Kit", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2", "k_number": [ "K950924", "K942677", "K912443", "K955717" ], "registration_number": [ "2029015", "3005595283", "1055236", "3015895045", "9616088", "3045816907", "3010041511", "3005012805", "1928237", "3035642068", "1423537", "3045816902", "3007289408", "3010885402", "3004605321", "2431166", "1061124", "3011137372", "3014925393", "1043214", "3013868968", "3015241782", "3014325891", "3004911384", "3008513424", "3004122598", "1054241", "2320762", "3003418325", "2433012", "1030451", "3007329020", "3004111573", "3015058854", "1060680", "9611102", "1423395", "1418479", "3015612252", "3004362278", "3011063460", "3009888344", "1047429", "1643817", "3001675293", "3015173212", "3016832577" ], "fei_number": [ "3005595283", "1000512168", "3015895045", "2523865", "1000208624", "3045816907", "3010041511", "3005012805", "1928237", "3035642068", "3045816902", "3007289408", "3010885402", "3004605321", "3014925393", "1000112968", "1043214", "3013868968", "3015241782", "3014325891", "3004911384", "3008513424", "3004122598", "3003418325", "3001236905", "1000112877", "3002902735", "3005747797", "2433012", "1030451", "3007329020", "1000160458", "3004111573", "3015058854", "3000717925", "1418479", "3015612252", "3004362278", "3002808001", "3011063460", "3009888344", "1047429", "1643817", "3001675293", "3015173212", "3003040625", "3016832577" ] } } ] }