Beaver-Visitec Recalls Ophthalmic Kits with Defective Devon Light Gloves
Beaver-Visitec International Inc. is recalling 268 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 defect compromises sterility, posing a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beaver-Visitec International Inc. is recalling 268 BVI Custom Eyes Ophthalmic Procedure Kits. The recall involves kits containing the Devon Light Glove, Part Number 584676. The specific lot numbers affected are 3068113, 3078510, 3086351, 3089841, and 3096796.
The recall was initiated because the Devon Light Gloves in these kits may have holes or slits. This defect compromises the sterility of the product, which is a critical requirement for ophthalmic surgical kits.
The affected kits were distributed nationwide, including in Kentucky, Georgia, Michigan, and New Jersey. Healthcare facilities and consumers should stop using these kits and contact the manufacturer for further instructions.
The recalled product
- Product
- BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
- Manufacturer
- Beaver-Visitec International Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 268
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: 3068113 3078510 3086351 3089841 3096796
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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