Beaver-Visitec Recalls Ophthalmic Kits with Defective Sterile Gloves
Beaver-Visitec is recalling 214 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a sterility defect poses a risk of harm (infection), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Beaver-Visitec International Inc. is recalling 214 BVI Custom Eyes Ophthalmic Procedure Kits. The recall is due to a defect in the Devon Light Glove component (Part Number: 584671), which may contain holes or slits that compromise the sterility of the product.
The affected kits were distributed nationwide, including in Kentucky, Georgia, Michigan, and New Jersey. The specific lot numbers involved are 3045852, 3053258, 3063193, and 3068829.
Healthcare providers and consumers should stop using these kits immediately and contact the manufacturer for instructions on return or replacement. Using non-sterile gloves during ophthalmic procedures poses a risk of infection.
The recalled product
- Product
- BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
- Manufacturer
- Beaver-Visitec International Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 214
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 Numbers: 3045852 3053258 3063193 3068829
Distribution
Part of a larger recall action
This product is one of 5 recalled by Beaver-Visitec International Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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