Reported Feb 7, 2024 · Ongoing
Custom procedural convenience kits and trays, general hospital 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, general hospital use, labeled as
18 of 18 products
| # | Product as published |
|---|---|
| 1 | IR NEURO PACK, kit number AGNE20J |
| 2 | ADULT CRANIOTOMY PACK, kit number LLCR99 |
| 3 | LAMINECTOMY PACK, kit number LLLC26 |
| 4 | KIT, CRANIOTOMY, kit number MMCR11J |
| 5 | KIT, NEURO SPINE, kit number MMNS20H |
| 6 | IR NEURO PACK, kit number OSIN77 |
| 7 | NEURO SAH, kit number SANE32H |
| 8 | NEURO SAH, kit number SANE32I |
| 9 | S78FCH CRANI PACK (PS 132432), kit number UICR10U |
| 10 | CRANI PACK (PS039498), kit number UICR33AW |
| 11 | Laminectomy, kit number UILM77AR |
| 12 | DIAGNOSTIC NEURO IR TRAY, kit number WENE21D |
| 13 | DIAGNOSTIC NEURO IR TRAY, kit number WENE21F |
| 14 | DIAGNOSTIC NEURO IR TRAY, kit number WENE21H |
| 15 | DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01 |
| 16 | NEURO IR TRAY, kit number WENI56F |
| 17 | NEURO IR TRAY, kit number WENI56H |
| 18 | NEURO IR TRAY, kit number WENI56H-01 |
- Lot codes and dates
18 of 18 products
Products covered by this recall # Barcodes Product as published 1 00191072183187AGNE20J, UDI/DI 00191072183187, Lot Numbers: 934231, exp. 10/30/2023; 900231, exp. 4/10/2024; 990231, exp. 1/10/2024; 687221, exp. 11/9/2023; 720221, exp. 10/7/2023; 757221, exp. 8/31/2023; 870221, exp. 5/10/2023; 702221, exp. 10/25/2023; 795221, exp. 7/24/2023 2 00191072162755LLCR99, UDI/DI 00191072162755, Lot Numbers: 756221, exp. 9/1/2023; 720221, exp. 10/7/2023; 654221, exp. 12/12/2023; 949231, exp. 2/20/2024 3 00191072171900LLLC26, UDI/DI 00191072171900, Lot Numbers: 749221, exp. 9/8/2023; 695221, exp. 11/1/2023; 997231, exp. 1/3/2024; 920231, exp. 3/21/2024 4 MMCR11J, UDI/DI none, Lot Numbers: 744221, exp. 9/13/2023; 939231, exp. 3/2/2024; 876231, exp. 5/4/2024 5 MMNS20H, UDI/DI none, Lot Numbers: 963231, exp. 2/6/2024; 959231, exp. 2/10/2024 6 0019107217070500191072190031OSIN77, UDI/DI 00191072170705, Lot Numbers: 780221, exp. 8/8/2023; 728221, exp. 9/29/2023; 668221, exp. 11/28/2023; 991231, exp. 1/9/2024, 960231, exp. 2/9/2024; 939231, exp. 3/2/2024; UDI/DI 00191072190031, Lot Numbers: 912231, exp. 3/29/2024; 903231, exp. 4/7/2024 7 SANE32H, UDI/DI none, Lot Numbers: 838221, exp. 6/11/2023; 889221, exp. 4/21/2023 8 SANE32I, UDI/DI none, Lot Numbers: 673221, exp. 11/23/2023; 730221, exp. 9/27/2023; 784221, exp. 8/4/2023; 911231, exp. 3/30/2024; 969231, exp. 1/31/2024 9 UICR10U, UDI/DI none, Lot Numbers: 990231, exp. 1/10/2024; 921231, exp. 3/20/2024; 885231, exp. 4/25/2024 10 UICR33AW, UDI/DI none, Lot Numbers: 658221, exp. 12/8/2023; 931231, exp. 3/10/2024; 876231, exp. 5/4/2024 11 00191072139184UILM77AR, UDI/DI 00191072139184, Lot Numbers: 953231, exp. 2/16/2024; 905231, exp. 4/5/2024 12 00191072167958WENE21D, UDI/DI 00191072167958, Lot Numbers: 839221, exp. 6/10/2023 13 00191072167958WENE21F, UDI/DI 00191072167958, Lot Numbers: 819221, exp. 6/30/2023 14 00191072179326WENE21H, UDI/DI 00191072179326, Lot Numbers: 729221, exp. 9/28/2023; 686221, exp. 11/10/2023 15 00191072179326WENE21H-01, UDI/DI 00191072179326, Lot Numbers: 980231, exp. 1/20/2024 16 00191072169341WENI56F, UDI/DI 00191072169341, Lot Numbers: 799221, exp. 7/20/2023 17 00191072179333WENI56H, UDI/DI 00191072179333, Lot Numbers: 700221, exp. 10/27/2023 18 00191072179333WENI56H-01, UDI/DI 00191072179333, Lot Numbers: 652221, exp. 12/14/2023; 996231, exp. 1/4/2024 - Amount recalled
- 2717 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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