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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- American Contract Systems, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0825-2024
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American Contract Systems
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American Contract Systems
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.