Recall archive / FDA device enforcement
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J;... — FDA record Z-0827-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 29, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number OSIN77; g) NEURO SAH, kit number SANE32H; h) NEURO SAH, kit number SANE32I; i) S78FCH CRANI PACK (PS 132432), kit number UICR10U; j) CRANI PACK (PS039498), kit number UICR33AW; k) Laminectomy, kit number UILM77AR; l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D; m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F; n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H; o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01; p) NEURO IR TRAY, kit number WENI56F; q) NEURO IR TRAY, kit number WENI56H; r) NEURO IR TRAY, kit number WENI56H-01
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 2717 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0827-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) AGNE20J, 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; b) LLCR99, 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; c) LLLC26, 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; d) MMCR11J, UDI/DI none, Lot Numbers: 744221, exp. 9/13/2023; 939231, exp. 3/2/2024; 876231, exp. 5/4/2024; e) MMNS20H, UDI/DI none, Lot Numbers: 963231, exp. 2/6/2024; 959231, exp. 2/10/2024; f) OSIN77, 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; g) SANE32H, UDI/DI none, Lot Numbers: 838221, exp. 6/11/2023; 889221, exp. 4/21/2023; h) 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; i) UICR10U, UDI/DI none, Lot Numbers: 990231, exp. 1/10/2024; 921231, exp. 3/20/2024; 885231, exp. 4/25/2024; j) UICR33AW, UDI/DI none, Lot Numbers: 658221, exp. 12/8/2023; 931231, exp. 3/10/2024; 876231, exp. 5/4/2024; k) UILM77AR, UDI/DI 00191072139184, Lot Numbers: 953231, exp. 2/16/2024; 905231, exp. 4/5/2024; l) WENE21D, UDI/DI 00191072167958, Lot Numbers: 839221, exp. 6/10/2023; m) WENE21F, UDI/DI 00191072167958, Lot Numbers: 819221, exp. 6/30/2023; n) WENE21H, UDI/DI 00191072179326, Lot Numbers: 729221, exp. 9/28/2023; 686221, exp. 11/10/2023; o) WENE21H-01, UDI/DI 00191072179326, Lot Numbers: 980231, exp. 1/20/2024; p) WENI56F, UDI/DI 00191072169341, Lot Numbers: 799221, exp. 7/20/2023; q) WENI56H, UDI/DI 00191072179333, Lot Numbers: 700221, exp. 10/27/2023; r) WENI56H-01, UDI/DI 00191072179333, Lot Numbers: 652221, exp. 12/14/2023; 996231, exp. 1/4/2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 7, 2024
- Recall initiation date
- Nov 29, 2023
- Center classification date
- Jan 26, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.