CYSTO , Model No SACY80R
- Company
- American Contract Systems Inc
- Recall Initiated
- February 6, 2025
- Posted
- March 14, 2025
- Recall Number
- Z-1346-2025
- Quantity
- 144 kits
- Firm Location
- Tiffin, OH
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 00191072223425 Lots 70-51139 70-052248 70-052564 70-052954
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.
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