Reported Feb 7, 2024 · Ongoing
Custom procedural convenience kits and trays, gastroenterological & urological, 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, gastroenterological & urological, labeled as
22 of 22 products
| # | Product as published |
|---|---|
| 1 | LAP KIDNEY MODULE, kit number AGKD50L |
| 2 | ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S |
| 3 | LAP CHOLE - 213388, kit number BFLC02AD |
| 4 | GENERAL LAPAROSCOPY PACK, kit number GUGE09I |
| 5 | LAP CHOLE PACK, kit number HNLC80I |
| 6 | Lap Chole Ovarian Appy, kit number JSLC06I |
| 7 | LAP CHOLE, ST LUKES, kit number LMLP08Z |
| 8 | ROBOTIC PACK - 242561, kit number MHRB88AJ |
| 9 | KIT, GENERAL LAPAROSCOPY, kit number MMLP40F |
| 10 | KIT, MAJOR LAPAROTOMY, kit number MMML26F |
| 11 | LAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K |
| 12 | GENERAL LAPAROSCOPY SAH, kit number SAGL57H |
| 13 | ROBOTIC PACK SAH, kit number SARB30K |
| 14 | ROBOTIC PACK SAH, kit number SARB30L |
| 15 | ROBOTIC PACK SAH, kit number SARB30M |
| 16 | LAP CHOLE PACK, kit number SMLC53 |
| 17 | ROBOTICS PACK, kit number SNRP85D |
| 18 | ROBOTIC PACK, kit number SSRO22C |
| 19 | ROBOTIC PACK, kit number SSRO22D |
| 20 | TPK DAVINCI PROSTATE SYSTEM, kit number TPDV16 |
- Lot codes and dates
22 of 22 products
Products covered by this recall # Barcodes Product as published 1 00191072141156AGKD50L, UDI/DI 00191072141156, Lot Numbers: 905231, exp. 4/5/2024; 638221, exp. 12/28/2023; 689221, exp. 5/21/2023 2 00191072171351ANPR34S, 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 3 0019107216907500191072188830BFLC02AD, 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 4 GUGE09I, UDI/DI none, Lot Numbers: 768221, exp. 8/20/2023 5 00191072146267HNLC80I, 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 6 00191072126061JSLC06I, UDI/DI 00191072126061, Lot Numbers: 839221, exp. 6/10/2023; 766221, exp. 8/22/2023 7 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 8 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 9 MMLP40F, UDI/DI none, Lot Numbers: 933231, exp. 3/8/2024; 879231, exp. 5/1/2024 10 MMML26F, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 896231, exp. 4/14/2024 11 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 12 SAGL57H, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 790221, exp. 7/29/2023 13 SARB30K, UDI/DI none, Lot Numbers: 845221, exp. 6/4/2023; 888221, exp. 4/22/2023 14 SARB30L, UDI/DI none, Lot Numbers: 752221, exp. 9/5/2023 15 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 16 00191072188465SMLC53, UDI/DI 00191072188465, Lot Numbers: 969231, exp. 1/31/2024 17 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 18 SSRO22C, UDI/DI none, Lot Numbers: 891221, exp. 04/19/2023 19 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 20 00191072128904TPDV16, 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 - Amount recalled
- 3196 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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