FDA Device recall Z-2468-2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W by American Contract Systems, citing during an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for furthe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2468-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-14 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | IL, LA |
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Reason
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Identifiers
| code_info | 1) MODEL/ITEM NUMBER UICR10W: UDI/DI 00191072207241, Kit Lot Numbers: 42-7828711, 42-7980711, 42-8063211, 42-8124011;…1) MODEL/ITEM NUMBER UICR10W: UDI/DI 00191072207241, Kit Lot Numbers: 42-7828711, 42-7980711, 42-8063211, 42-8124011; 2) MODEL/ITEM NUMBER UISH55V: UDI/DI 00191072235442, Kit Lot Numbers: 42-7799111, 42-7985211, 42-8065111, 42-8140711. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2468-2025%22
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