Beaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves
Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves 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 (sterility compromise) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Beaver-Visitec International Inc. is recalling 384 BVI Custom Eyes Ophthalmic Procedure Kits. The recall is due to a defect in the Devon Light Glove component (Part Number 584648), 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 3038787, 3046210, 3061080, 3078492, 3093681, 3095940, and 3108668.
Healthcare facilities and consumers should stop using these kits and contact the manufacturer for further instructions. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
- Manufacturer
- Beaver-Visitec International Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 384
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: 3038787 3046210 3061080 3078492 3093681 3095940 3108668
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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