Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility
Beaver-Visitec International is recalling 621 ophthalmic procedure kits because the included Devon Light Glove 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 is classified as FDA Class II and involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Beaver-Visitec International Inc. is recalling 621 units of BVI Custom Eyes Ophthalmic Procedure Kits. The recall is due to a defect in the Devon Light Glove component (Part Number: 584569), 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 3035614, 3046205, 3052693, 3055885, 3063181, 3068806, 3073917, and 3082315.
Healthcare providers and consumers should stop using these kits and contact the manufacturer for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
- Manufacturer
- Beaver-Visitec International Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 621
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
- HighFDA Recalls Devon Light Gloves for Sterility Compromising Defects
FDA (Devices) · 2015-07-29
- HighRecall of Sterile Major Kits with Defective Devon Light Gloves
FDA (Devices) · 2015-07-29
- HighSurgical Kits Recalled Due to Glove Splits Compromising Sterility
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- HighMinor Surgical Kits Recalled Due to Sterility Compromise in Gloves
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- HighFDA Recalls Sterile Devon Light Gloves Due to Splits and Holes
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- SevereFDA Recalls Sterile Surgical Kits with Compromised Gloves
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