Z-1658-2025 Class II Ongoing
FDA device recall Z-1658-2025 was initiated by Edge Biologicals Inc on October 2, 2023 and is designated Class II. Reason for recall: Due to product outer packaging incorrectly labeled. The recall status is ongoing. Affected quantity: 660 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- October 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 660 units
Product Description
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
Reason for Recall
Due to product outer packaging incorrectly labeled.
Distribution Pattern
U.S. Nationwide distribution in the state of PA.
Code Information
Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223