Edge Biologicals Sterile Water incorrectly labeled product packaging
Edge Biologicals is recalling Sterile Water, 3mL (Product Number T-0780, Lot 01223) due to incorrect labeling on the product's outer packaging. The affected units were distributed nationwide in Pennsylvania.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves incorrect labeling on product packaging only, with no reported health risks, adverse events, or safety hazards. This is a labeling/documentation issue characteristic of FDA Class III recalls, which the rubric places at severity score 1 or 2.
Plain-English summary
Edge Biologicals Inc is recalling Sterile Water, 3mL, 100/PK (CAT T-0780) due to incorrect labeling on the product's outer packaging. The sterile water is used in microbial testing preparation and for diluting sterile reagents and microorganism preparations.
Approximately 660 units with Lot Number 01223 and UDI-DI code B645T-07803012232023012320240123100E were distributed nationwide in the state of Pennsylvania.
Healthcare facilities and laboratories that received this product should verify that the outer packaging labeling matches the actual contents. Customers with questions or concerns should contact Edge Biologicals Inc.
The recalled product
- 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…
- Manufacturer
- Edge Biologicals Inc
- Hazard
- Affected units
- 660
Distribution
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