Device product
MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
Z-1455-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0
- Official record key
device-enforcement:Z-1455-2024
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 20193489190844 (case)10193489190847 (each), Lot Numbers: 2023071290 (not distributed)
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