NEURO IR TRAY , Model No WENI56J
This recall is currently active, issued March 14, 2025. It was issued by American Contract Systems Inc.
- Company
- American Contract Systems Inc
- Recall Initiated
- February 6, 2025
- Posted
- March 14, 2025
- Recall Number
- Z-1355-2025
- Quantity
- 120 kits
- Firm Location
- Tiffin, OH
- Official Source
- View on FDA website ↗
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Distribution
US Nationwide distribution in the state of OH.
Lot / Code Info
UDI-DI 00191072217813 Lots 893241 71-051182 71-051813
Root Cause
Process control
Action Taken
The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.