Recall archive / FDA device enforcement

Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC,... — FDA record Z-0825-2024

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, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number LVEV61; m) MAJOR PACK, kit number LVMJ21; n) HEAD AND NECK PACK, kit number MMHN37F; o) KIT, MINOR U BAR, kit number MMNU34E; p) KIT, MAJOR UNIVERSAL, kit number MMUN28E; q) VAG PLASTY PACK, kit number OSVP16; r) DR L MAJOR, kit number SALM40H; s) DR L MAJOR, kit number SALM40I; t) MINOR BASIN SAH, kit number SAMB25E; u) MAJOR SAH, kit number SAMJ36G; v) MINOR PACK, kit number SMMN65; w) General Pack, kit number THGN59D; x) MINOR PACK, kit number TPMN15; y) MAJOR UNIVERSAL PACK, kit number TPUN48
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: 7881 units
Agency-reported status: Ongoing
Source record identifier: Z-0825-2024

Open the official record

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

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a) AGBR90E, UDI/DI 00191072036865, Lot Numbers: 959231, exp. 02/10/2024; 681221, exp. 11/15/2023; 721221, exp. 09/30/2023; 771221, exp. 08/147/2023; 827221, exp. 06/22/2023; 897221, exp. 04/13/2023; b) AGMM60M, UDI/DI 00191072063786, Lot Numbers: 939231, exp. 03/02/2024; 638221, exp. 4528812/28/2023; 694221, exp. 11/02/2023; 734221, exp. 09/23/2023; 769221, exp. 08/19/2023; c) AHPO55J, UDI/DI 00191072171566, Lot Numbers: 682221, exp. 11/14/2023; 661221, exp. 12/5/2023; 977231, exp. 1/23/2024; 945231, exp. 2/24/2024; 891231, exp. 4/19/2024; d) BBGP31C, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 738221, exp. 9/19/2023; 805221, exp. 7/14/2023; 870221, exp. 5/10/2023; e) FDFT75N, UDI/DI none, Lot Numbers: 773221, exp. 8/15/2023; 714221, exp. 10/13/2023; 990231, exp. 1/10/2024; 935231, exp. 3/6/2024; 890231, exp. 4/20/2024; 870231, exp. 5/10/2024; f) HCAR04K, UDI/DI 00191072114174, Lot Numbers: 757221, exp. 08/31/2023; g) HGBA92F, UDI/DI none, Lot Numbers: 757221, exp. 8/31/2023; 695221, exp. 11/1/2023; 635221, exp. 12/31/2023; h) HNLP12J, UDI/DI 00191072146274, Lot Numbers: 805221, exp. 7/14/2023; 742221, exp. 9/15/2023; 673221, exp. 11/23/2023; 924231, exp. 3/17/2024; i) HSMD20E, UDI/DI 00191072130068, Lot Numbers: 898221, exp. 4/12/2023; 772221, exp. 8/16/2023; 984231, exp. 1/16/2024; j) JSMI10I, UDI/DI none, Lot Numbers: 766221, exp. 08/22/2023; k) LVEV61, UDI/DI 00191072033475, Lot Numbers: 678221, exp. 11/18/2023; 637221, exp. 12/29/2023; l) LVMJ21, UDI/DI 00191072139023, Lot Numbers: 833221, exp. 6/16/2023; 764221, exp. 8/24/2023; 717221, exp. 10/10/2023; 988231, exp. 1/12/2024; 954231, exp. 2/15/2024; m) MMHN37F, UDI/DI none, Lot Numbers: 639221, exp. 12/27/2023; n) MMNU34E, UDI/DI none, Lot Numbers: 928231, exp. 3/13/2024; 889231, exp. 4/21/2024; o) MMUN28E, UDI/DI none, Lot Numbers: 889231, exp. 04/21/2024; p) OSVP16, UDI/DI 00191072156570, Lot Numbers: 827221, exp. 6/17/2023; q) OSVP16, UDI/DI 00191072170835, Lot Numbers: 700221, exp. 10/23/2023; 644221, exp. 12/4/2023; 987231, exp. 11/20/2023; r) SALM40H, UDI/DI none, Lot Numbers: 826221, exp. 6/23/2023; 888221, exp. 4/22/2023; s) SALM40I, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 756221, exp. 9/1/2023; 984231, exp. 1/16/2024; t) SAMB25E, UDI/DI none, Lot Numbers: 843221, exp. 6/6/2023; 894221, exp. 4/16/2023; 871221, exp. 5/9/2023; 686221, exp. 11/10/2023; 758221, exp. 8/30/2023; 793221, exp. 7/26/2023; 974231, exp. 1/26/2024; u) SAMJ36G, UDI/DI none, Lot Numbers: 660221, exp. 12/6/2023; 704221, exp. 10/23/2023; 752221, exp. 9/5/2023; 800221, exp. 7/19/2023; v) SMMN65, UDI/DI 00191072188472, Lot Numbers: 969231, exp. 1/31/2024; 926231, exp. 3/15/2024; w) SMMN65, UDI/DI none, Lot Numbers: 919231, exp. 3/22/2024; x) THGN59D, UDI/DI 00191072191069, Lot Numbers: 805221, exp. 7/14/2023; 721221, exp. 10/6/2023; y) TPMN15, UDI/DI 00191072171771, Lot Numbers: 737221, exp. 9/20/2023; 702221, exp. 10/25/2023; 664221, exp. 12/2/2023; 990231, exp. 1/10/2024; 960231, exp. 2/9/2024; 939231, exp. 3/2/2024; 903231, exp. 4/7/2024; z) TPUN48, UDI/DI 00191072171832, Lot Numbers: 738221, exp. 9/19/2023; 688221, exp. 11/8/2023; 637221, exp. 12/29/2023; 967231, exp. 2/2/2024; 924231, exp. 3/17/2024

Label field

Details supplied by the agency

Lot, code or applicability

a) AGBR90E, UDI/DI 00191072036865, Lot Numbers: 959231, exp. 02/10/2024; 681221, exp. 11/15/2023; 721221, exp. 09/30/2023; 771221, exp. 08/147/2023; 827221, exp. 06/22/2023; 897221, exp. 04/13/2023; b) AGMM60M, UDI/DI 00191072063786, Lot Numbers: 939231, exp. 03/02/2024; 638221, exp. 4528812/28/2023; 694221, exp. 11/02/2023; 734221, exp. 09/23/2023; 769221, exp. 08/19/2023; c) AHPO55J, UDI/DI 00191072171566, Lot Numbers: 682221, exp. 11/14/2023; 661221, exp. 12/5/2023; 977231, exp. 1/23/2024; 945231, exp. 2/24/2024; 891231, exp. 4/19/2024; d) BBGP31C, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 738221, exp. 9/19/2023; 805221, exp. 7/14/2023; 870221, exp. 5/10/2023; e) FDFT75N, UDI/DI none, Lot Numbers: 773221, exp. 8/15/2023; 714221, exp. 10/13/2023; 990231, exp. 1/10/2024; 935231, exp. 3/6/2024; 890231, exp. 4/20/2024; 870231, exp. 5/10/2024; f) HCAR04K, UDI/DI 00191072114174, Lot Numbers: 757221, exp. 08/31/2023; g) HGBA92F, UDI/DI none, Lot Numbers: 757221, exp. 8/31/2023; 695221, exp. 11/1/2023; 635221, exp. 12/31/2023; h) HNLP12J, UDI/DI 00191072146274, Lot Numbers: 805221, exp. 7/14/2023; 742221, exp. 9/15/2023; 673221, exp. 11/23/2023; 924231, exp. 3/17/2024; i) HSMD20E, UDI/DI 00191072130068, Lot Numbers: 898221, exp. 4/12/2023; 772221, exp. 8/16/2023; 984231, exp. 1/16/2024; j) JSMI10I, UDI/DI none, Lot Numbers: 766221, exp. 08/22/2023; k) LVEV61, UDI/DI 00191072033475, Lot Numbers: 678221, exp. 11/18/2023; 637221, exp. 12/29/2023; l) LVMJ21, UDI/DI 00191072139023, Lot Numbers: 833221, exp. 6/16/2023; 764221, exp. 8/24/2023; 717221, exp. 10/10/2023; 988231, exp. 1/12/2024; 954231, exp. 2/15/2024; m) MMHN37F, UDI/DI none, Lot Numbers: 639221, exp. 12/27/2023; n) MMNU34E, UDI/DI none, Lot Numbers: 928231, exp. 3/13/2024; 889231, exp. 4/21/2024; o) MMUN28E, UDI/DI none, Lot Numbers: 889231, exp. 04/21/2024; p) OSVP16, UDI/DI 00191072156570, Lot Numbers: 827221, exp. 6/17/2023; q) OSVP16, UDI/DI 00191072170835, Lot Numbers: 700221, exp. 10/23/2023; 644221, exp. 12/4/2023; 987231, exp. 11/20/2023; r) SALM40H, UDI/DI none, Lot Numbers: 826221, exp. 6/23/2023; 888221, exp. 4/22/2023; s) SALM40I, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 756221, exp. 9/1/2023; 984231, exp. 1/16/2024; t) SAMB25E, UDI/DI none, Lot Numbers: 843221, exp. 6/6/2023; 894221, exp. 4/16/2023; 871221, exp. 5/9/2023; 686221, exp. 11/10/2023; 758221, exp. 8/30/2023; 793221, exp. 7/26/2023; 974231, exp. 1/26/2024; u) SAMJ36G, UDI/DI none, Lot Numbers: 660221, exp. 12/6/2023; 704221, exp. 10/23/2023; 752221, exp. 9/5/2023; 800221, exp. 7/19/2023; v) SMMN65, UDI/DI 00191072188472, Lot Numbers: 969231, exp. 1/31/2024; 926231, exp. 3/15/2024; w) SMMN65, UDI/DI none, Lot Numbers: 919231, exp. 3/22/2024; x) THGN59D, UDI/DI 00191072191069, Lot Numbers: 805221, exp. 7/14/2023; 721221, exp. 10/6/2023; y) TPMN15, UDI/DI 00191072171771, Lot Numbers: 737221, exp. 9/20/2023; 702221, exp. 10/25/2023; 664221, exp. 12/2/2023; 990231, exp. 1/10/2024; 960231, exp. 2/9/2024; 939231, exp. 3/2/2024; 903231, exp. 4/7/2024; z) TPUN48, UDI/DI 00191072171832, Lot Numbers: 738221, exp. 9/19/2023; 688221, exp. 11/8/2023; 637221, exp. 12/29/2023; 967231, exp. 2/2/2024; 924231, exp. 3/17/2024

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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records