C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
FDA device recall Z-1336-2025 · posted 2025-03-14 · Open, Classified
Recall details
- Recalling firm
- American Contract Systems Inc
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OHM
- Quantity affected
- 252 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Date initiated
- 2025-02-06
- Date posted
- 2025-03-14
- Location
- Tiffin, OH
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