Device product
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Z-1453-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2458 units
- Official record key
device-enforcement:Z-1453-2024
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 20193489190790 (case) 10193489190793 (each), Lot Numbers: 2023071290, 2023091890
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