AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS...
FDA Recall #Z-2468-2025 — Class II — July 14, 2025
Product Description
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 for Recall
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.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
204 units
Distribution
US distribution to states of: IL and LA
Code Information
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
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated