Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility
Beaver-Visitec International is recalling 585 ophthalmic procedure kits because the Devon Light Glove component may have holes or slits that compromise sterility.
What this means for you
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 risk-of-harm product (compromised sterility leading to potential infection) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Beaver-Visitec International Inc. is recalling 585 BVI Custom Eyes Ophthalmic Procedure Kits. The recall is due to a defect in the Devon Light Glove component (Part Number: 584649), 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 3039720, 3046211, 3047770, 3049473, 3070763, 3082330, 3089827, 3093682, 3095941, 3106407, and 3117874.
Healthcare facilities and consumers should stop using these kits immediately and contact the manufacturer for instructions on return or replacement. Using non-sterile surgical instruments poses a risk of infection.
The recalled product
- Product
- BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
- Manufacturer
- Beaver-Visitec International Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 585
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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