Beaver-Visitec Recalls Hemostatic Eraser Bipolar Due to Incorrect Labeling
Beaver-Visitec International Inc. is recalling 1,025 units of Wet-Field Hemostatic Eraser Bipolar 25G instruments because they were packaged with incorrect labeling.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the source text explicitly states the issue is incorrect labeling and does not report any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors without reported harm.
Plain-English summary
Beaver-Visitec International Inc. is recalling 1,025 units of Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP instruments. The recall is due to the products being packaged with incorrect labeling. The affected products have Part Number 221267, UDI 30886158010549, and Lot number 6001035.
The recall covers distribution in the United States and Canada. The source text does not specify the exact number of affected units beyond the total quantity listed, nor does it provide specific dates of distribution or specific healthcare facilities affected.
Healthcare providers and consumers should stop using the affected instruments and contact Beaver-Visitec International Inc. for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
- Manufacturer
- Beaver-Visitec International Inc.
- Hazard
- Affected units
- 1,025
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 6001035
Distribution
Distributed nationwide across the United States.
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