Reported Feb 7, 2024 · Ongoing
Custom procedural convenience kits and trays, cardiac, 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, cardiac, labeled as
5 of 5 products
| # | Product as published |
|---|---|
| 1 | HEART CATHETERIZATION TRAY, kit number JRHC45G |
| 2 | TAVR PACK, kit number LLTV10 |
| 3 | CATH PED LF SJH, kit number SJCA21F |
| 4 | CATH HEART ADL LF SJH, kit number SJCH22F |
| 5 | INT RAD PORTS-LF - 206060, kit number UDIR58AL |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 00191072164240JRHC45G, UDI/DI 00191072164240, Lot Numbers: 912231, exp. 3/29/2024; 920231, exp. 3/21/2024; 952231, exp. 2/17/2024; 963231, exp. 2/6/2024; 976231, exp. 6/2/2023; 654221, exp. 12/12/2023; 714221, exp. 10/13/2023; 717221, exp. 6/7/2023; 766221, exp. 8/22/2023; 814221, exp. 7/5/2023 2 00191072183255LLTV10, UDI/DI 00191072183255, Lot Numbers: 644221, exp. 12/22/2023; 973231, exp. 1/27/2024; 952231, exp. 2/17/2024; 924231, exp. 3/17/2024 3 SJCA21F, UDI/DI None, Lot Numbers: 666221, exp. 11/30/2023; 701221, exp. 10/26/2023; 747221, exp. 9/10/2023; 779221, exp. 8/9/2023; 807221, exp. 7/12/2023; 846221, exp. 6/3/2023; 919231, exp. 3/22/2024; 954231, exp. 2/15/2024; 988231, exp. 1/12/2024 4 SJCH22F, UDI/DI None, Lot Numbers: 670221, exp. 11/26/2023; 708221, exp. 10/19/2023; 747221, exp. 9/10/2023; 795221, exp. 7/24/2023; 834221, exp. 6/15/2023; 873221, exp. 5/7/2023; 937231, exp. 3/4/2024; 991231, exp. 1/9/2024 5 UDIR58AL, UDI/DI None, Lot Numbers: 682221, exp. 11/14/2023; 638221, exp. 7/31/2023; 963231, exp. 2/6/2024; 925231, exp. 3/16/2024; 883231, exp. 10/30/2023 - Amount recalled
- 4394 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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