Reported Feb 7, 2024 · Ongoing
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, 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, Obstetrical & Gynecological use, labeled as
11 of 11 products
| # | Product as published |
|---|---|
| 1 | LOWER PELVIC PACK, kit number AGLP52L |
| 2 | OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G |
| 3 | DAVINCI GYN PACK, kit number HHDV17 |
| 4 | KIT, GYNE ROBOTIC, kit number MMGR44D |
| 5 | KIT, MAJOR LITHOTOMY, kit number MMJL16E |
| 6 | GYN PACK, kit number SMGY46 |
| 7 | Lithotomy Pack, kit number THLH71C |
| 8 | ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA |
| 9 | GYN LAPAROSCOPY HPES, kit number WELP67C |
| 10 | GYN LAPAROSCOPY HPES, kit number WELP67C-01 |
| 11 | GYN LAPAROSCOPY HPES, kit number WELP67C-02 |
- Lot codes and dates
11 of 11 products
Products covered by this recall # Barcodes Product as published 1 00191072144119AGLP52L, UDI/DI 00191072144119, Lot Numbers: 933231, exp. 3/8/2024; 942231, exp. 2/27/2024; 947231, exp. 2/22/2024; 966231, exp. 2/3/2024; 980231, exp. 1/20/2024; 681221, exp. 11/15/2023; 707221, exp. 10/20/2023 2 HGOB98G, UDI/DI none, Lot Numbers: 667221, exp. 11/29/2023; 977231, exp. 1/23/2024; 952231, exp. 1/31/2024; 896231, exp. 1/31/2024 3 00191072170125HHDV17, UDI/DI 00191072170125, Lot Numbers: 766221, exp. 8/22/2023; 731221, exp. 9/26/2023; 682221, exp. 11/14/2023; 638221, exp. 12/28/2023; 946231, exp. 2/23/2024 4 MMGR44D, UDI/DI none, Lot Numbers: 709221, exp. 10/18/2023; 650221, exp. 12/16/2023; 891231, exp. 4/19/2024 5 MMJL16E, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 920231, exp. 3/21/2024 6 00191072188458SMGY46, UDI/DI 00191072188458, Lot Numbers: 961231, exp. 2/8/2024 7 00191072155108THLH71C, UDI/DI 00191072155108, Lot Numbers: 756221, exp. 9/1/2023; 708221, exp. 10/19/2023 8 UIHY16AA, UDI/DI none, Lot Numbers: 931231, exp. 3/10/2024; 896231, exp. 4/14/2024 9 00191072173676WELP67C, UDI/DI 00191072173676, Lot Numbers: 751221, exp. 9/6/2023; 681221, exp. 9/13/2023 10 00191072173676WELP67C-01, UDI/DI 00191072173676, Lot Numbers: 720221, exp. 9/21/2023 11 00191072173676WELP67C-02, UDI/DI 00191072173676, Lot Numbers: 643221, exp. 9/13/2023 - Amount recalled
- 1020 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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