Device product
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
Z-1448-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1700 units
- Official record key
device-enforcement:Z-1448-2024
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) 15MLVLCP, UDI/DI 50653160021306 (case) 00653160021301 (each), Lot Numbers: 2023102790 b) MG912ST, UDI/DI 10653160122906 (case) 00653160122909 (each), Lot Numbers: 2023022190
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