Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile wa...
FDA Recall #Z-1658-2025 — Class II — October 2, 2023
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.
Recalling Firm
Edge Biologicals Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
660 units
Distribution
U.S. Nationwide distribution in the state of PA.
Code Information
Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated