Recall Z-1658-2025— Edge Biologicals Inc
Class II · Ongoing
Class II FDA medical device recall by Edge Biologicals Inc, initiated 2023-10-02. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Due to product outer packaging incorrectly labeled..
- Recalling firm
- Edge Biologicals Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-02
- Firm location
- Memphis, TN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.