Device product
Centurion STERILE #16 RUBBER BAND, Product Code EB16
Z-1446-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-1446-2024
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: UDI/DI 10653160129240 (case) 00653160129243 (each), Lot Numbers: 2023022290, 2023041190
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