FDAFDA · Food and drugs·Recall number Z-0822-2024

Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK, kit number HNLC80I; f) Lap Chole Ovarian Appy, kit number JSLC06I; g) LAP CHOLE, ST LUKES, kit number LMLP08Z; h) ROBOTIC PACK - 242561, kit number MHRB88AJ; i) KIT, GENERAL LAPAROSCOPY, kit number MMLP40F; j) KIT, MAJOR LAPAROTOMY, kit number MMML26F; k) LAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K; l) GENERAL LAPAROSCOPY SAH, kit number SAGL57H; m) ROBOTIC PACK SAH, kit number SARB30K; n) ROBOTIC PACK SAH, kit number SARB30L; o) ROBOTIC PACK SAH, kit number SARB30M; p) LAP CHOLE PACK, kit number SMLC53; q) ROBOTICS PACK, kit number SNRP85D; r) ROBOTIC PACK, kit number SSRO22C; s) ROBOTIC PACK, kit number SSRO22D; t) TPK DAVINCI PROSTATE SYSTEM, kit number TPDV16; u) ASC LAP CHOLE PACK (PS 42279), kit number UICH53Y; v) GENERAL LAPAROSCOPIC PACK, kit number WVGL60E

Published February 7, 2024 · Recall initiated: November 29, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer: American Contract Systems, Inc.
Distributor: US Nationwide distribution.
Lot: a) AGKD50L, UDI/DI 00191072141156, Lot Numbers: 905231, exp. 4/5/2024; 638221, exp. 12/28/2023; 689221, exp. 5/21/2023; b) ANPR34S, 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; c) BFLC02AD, 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; d) GUGE09I, UDI/DI none, Lot Numbers: 768221, exp. 8/20/2023; e) HNLC80I, 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; f) JSLC06I, UDI/DI 00191072126061, Lot Numbers: 839221, exp. 6/10/2023; 766221, exp. 8/22/2023; g) LMLP08Z, 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; h) MHRB88AJ, 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; i) MMLP40F, UDI/DI none, Lot Numbers: 933231, exp. 3/8/2024; 879231, exp. 5/1/2024; j) MMML26F, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 896231, exp. 4/14/2024; k) OWLC07K, 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; l) SAGL57H, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 790221, exp. 7/29/2023; m) SARB30K, UDI/DI none, Lot Numbers: 845221, exp. 6/4/2023; 888221, exp. 4/22/2023; n) SARB30L, UDI/DI none, Lot Numbers: 752221, exp. 9/5/2023; o) SARB30M, 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; p) SMLC53, UDI/DI 00191072188465, Lot Numbers: 969231, exp. 1/31/2024; q) SNRP85D, 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; r) SSRO22C, UDI/DI none, Lot Numbers: 891221, exp. 04/19/2023; s) SSRO22D, 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; t) TPDV16, 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; u) UICH53Y, UDI/DI none, Lot Numbers: 897231, exp. 4/13/2024; 882231, exp. 4/28/2024; v) WVGL60E, UDI/DI 00191072144034, Lot Numbers: 766221, exp. 8/22/2023; 694221, exp. 11/2/2023; 952231, exp. 2/17/2024;
Risk classification: Class II
Area (FDA): device
Country: United States

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