Device product
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
Z-1658-2025
Product summary
- Event
- Event 96497
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 660 units
- Official record key
device-enforcement:Z-1658-2025
Official wording
Reason: Due to product outer packaging incorrectly labeled.
Code information: Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223
Distribution pattern: U.S. Nationwide distribution in the state of PA.
Derived failure modes
-
Labeling or packaging
incorrectly labeled