Device product
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Z-1452-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4200 units
- Official record key
device-enforcement:Z-1452-2024
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 20193489111375 (case) 10193489111378 (each), Lot Numbers: 2023031590, 2023070390
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