Edge Biologicals Sterile Water Recalled for Incorrect Outer Packaging Label
Edge Biologicals is recalling Sterile Water, 3mL units due to incorrect labeling on the product's outer packaging. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall due to incorrect outer packaging labeling with no reported illnesses or injuries. Per the severity rubric, minor labeling errors on medical devices are classified as Moderate (score 2).
Plain-English summary
Edge Biologicals Inc is recalling Sterile Water, 3mL, 100/PK (Product Number T-0780) due to incorrect labeling on the product's outer packaging. The affected lot number is 01223, with 660 units distributed. This sterile water is used in laboratory settings for preparing dilutions of samples and transport media in microbial testing, and for diluting sterile reagents and microorganism preparations.
The product outer packaging has been incorrectly labeled, which could lead to confusion or improper use in laboratory settings.
The recalled product was distributed nationwide in the state of Pennsylvania.
Customers and laboratory personnel who have received this product should stop using it and contact Edge Biologicals Inc for further instructions or a replacement. No illnesses or injuries have been reported to date.
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 preparat
- Manufacturer
- Edge Biologicals Inc
- Hazard
- labeling-error
Distribution
Distributed nationwide across the United States.
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