Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making d
Summary
The FDA issued a Class II for Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 1 by Edge Biologicals Inc. Reason: Due to product outer packaging incorrectly labeled..
Details
Source
Device Recall
External ID
Z-1658-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
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
Lot/Code Info: Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223
Quantity Affected: 660 units
Reason for Recall
Due to product outer packaging incorrectly labeled.
Distribution
U.S. Nationwide distribution in the state of PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-02
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Edge Biologicals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Edge Biologicals Inc have FDA actions?
This is the only FDA action we have on record for Edge Biologicals Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1658-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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