Beaver Visitec Recalls Mislabeled Ophthalmic Slit Knives
Beaver Visitec is recalling 440 ophthalmic slit knives due to mislabeling on individual packages within correctly labeled cartons.
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 and involves a minor labeling error on individual packages within correctly labeled cartons, which fits the criteria for moderate severity.
Plain-English summary
Beaver Visitec is recalling 440 units of the Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726, used in ophthalmic surgery. The recall is due to a labeling error where individual packages of product 373726 (Lot 6001700) were mislabeled with the identification for product 374891 (Lot 6001701), although the shelf cartons were correctly labeled.
The affected products were distributed to the US states of California, Illinois, Maryland, Minnesota, New Jersey, Ohio, and Pennsylvania, as well as to Israel. The recall is limited to the specific lot and model number identified in the source text.
Consumers and healthcare facilities should check their inventory for the specific model and lot numbers listed. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
- Manufacturer
- Beaver Visitec
- Hazard
- Affected units
- 440
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 6001700
Distribution
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