Medical device recalls Moderate risk

Edge Biologicals Inc recalls Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilu…

Recall date
October 2, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1658-2025
FDA classification
Class II
Brand / firm
Edge Biologicals Inc
Sold / distributed
U.S. Nationwide distribution in the state of PA.

Why it was recalled

Due to product outer packaging incorrectly labeled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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