is it on recall

Recall archive / FDA device enforcement

Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit... — FDA record Z-0822-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 29, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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
Reason
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.
Classification
Class II
Recalling firm
American Contract Systems, Inc.
Quantity
3196 units
Agency-reported status
Ongoing
Source record identifier
Z-0822-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilitya) 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;

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Feb 7, 2024
Recall initiation date
Nov 29, 2023
Center classification date
Jan 26, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records

Medical devices recordsAmerican Contract Systems, Inc. records