Device product
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
Z-1436-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3860 units
- Official record key
device-enforcement:Z-1436-2024
Official wording
Reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Code information: a) 66825, UDI/DI 60653160053588 (case) 00653160053586 (each), Lot Numbers: 2023091990, 2023111590; b) I68290 UDI/DI 00653160275056 (case) 10653160275053 (each), Lot Numbers: 2023100690
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Derived failure modes
-
Labeling or packaging
weak seal
-
Sterility assurance
breach of sterility