Reported Feb 7, 2024 · Ongoing
Custom procedural convenience kits and trays, general & plastic surgery, labeled as
American Contract Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems, Inc. · 7802 E Telecom Pkwy · Temple Terrace, FL · 33637-0928
Is this the product you have?
Custom procedural convenience kits and trays, general & plastic surgery, labeled as
25 of 25 products
| # | Product as published |
|---|---|
| 1 | BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E |
| 2 | BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E |
| 3 | MINI MINOR AGH ASC PACK, kit number AGMM60M |
| 4 | OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J |
| 5 | General Pack, kit number BBGP31C |
| 6 | FRACTURE TABLE PACK, kit number FDFT75N |
| 7 | Arthroscopy Pack, kit number HCAR04K |
| 8 | BARIATRIC PACK, kit number HGBA92F |
| 9 | LAPAROTOMY PACK, kit number HNLP12J |
| 10 | MIDLINE CHANGE KIT, kit number HSMD20E |
| 11 | Minor General, kit number JSMI10I |
| 12 | ENDO VASCULAR PACK, kit number LVEV61 |
| 13 | MAJOR PACK, kit number LVMJ21 |
| 14 | HEAD AND NECK PACK, kit number MMHN37F |
| 15 | KIT, MINOR U BAR, kit number MMNU34E |
| 16 | KIT, MAJOR UNIVERSAL, kit number MMUN28E |
| 17 | VAG PLASTY PACK, kit number OSVP16 |
| 18 | DR L MAJOR, kit number SALM40H |
| 19 | DR L MAJOR, kit number SALM40I |
| 20 | MINOR BASIN SAH, kit number SAMB25E |
- Lot codes and dates
26 of 26 products
Products covered by this recall # Barcodes Product as published 1 00191072036865AGBR90E, 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 2 00191072063786AGMM60M, 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 3 00191072171566AHPO55J, 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 4 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 5 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 6 00191072114174HCAR04K, UDI/DI 00191072114174, Lot Numbers: 757221, exp. 08/31/2023 7 HGBA92F, UDI/DI none, Lot Numbers: 757221, exp. 8/31/2023; 695221, exp. 11/1/2023; 635221, exp. 12/31/2023 8 00191072146274HNLP12J, 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 9 00191072130068HSMD20E, UDI/DI 00191072130068, Lot Numbers: 898221, exp. 4/12/2023; 772221, exp. 8/16/2023; 984231, exp. 1/16/2024 10 JSMI10I, UDI/DI none, Lot Numbers: 766221, exp. 08/22/2023 11 00191072033475LVEV61, UDI/DI 00191072033475, Lot Numbers: 678221, exp. 11/18/2023; 637221, exp. 12/29/2023 12 00191072139023LVMJ21, 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 13 MMHN37F, UDI/DI none, Lot Numbers: 639221, exp. 12/27/2023 14 MMNU34E, UDI/DI none, Lot Numbers: 928231, exp. 3/13/2024; 889231, exp. 4/21/2024 15 MMUN28E, UDI/DI none, Lot Numbers: 889231, exp. 04/21/2024 16 00191072156570OSVP16, UDI/DI 00191072156570, Lot Numbers: 827221, exp. 6/17/2023 17 00191072170835OSVP16, UDI/DI 00191072170835, Lot Numbers: 700221, exp. 10/23/2023; 644221, exp. 12/4/2023; 987231, exp. 11/20/2023 18 SALM40H, UDI/DI none, Lot Numbers: 826221, exp. 6/23/2023; 888221, exp. 4/22/2023 19 SALM40I, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 756221, exp. 9/1/2023; 984231, exp. 1/16/2024 20 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 - Amount recalled
- 7881 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new American Contract Systems, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.