BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The voluntary recall affects approximately 1,629 units distributed nationwide.
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: This is an FDA Class II medical device recall for syringes used in medical procedures. Although no illnesses or injuries have been reported, the recall indicates a product issue with inherent risk of harm during medical use, meeting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs, Part Number 58001376, because they contain 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Specifically, the packs contain low dead space and luer slip tip syringes that are the subject of a voluntary recall by Sol-M.
Approximately 1,629 units of the affected CustomEyes Procedure Packs have been distributed nationwide. This recall is being conducted on a voluntary basis.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001376;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 1,629
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 (4)
- Part Number: 58001376
- UDI-DI:30886158031919
- Lot/Batch Number: 6062023
- 6064080
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 159 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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