FDA Recall
Open, Classified
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Recall: Z-1354-2025
·
Initiated February 6, 2025
Recall
- Recall Number
- Z-1354-2025
- Event Number
- 96343
- Firm
- American Contract Systems Inc
- FEI Number
- 3008492337
- Product Code
- OJG
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- February 6, 2025
- Posted
- March 14, 2025
- Address
- 85 Shaffer Park Dr, Tiffin, OH, 44883-9290
Description
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Reason
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Action
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.
Distribution
US Nationwide distribution in the state of OH.
Quantity
170 kits