BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Components
Beaver Visitec recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes subject to manufacturing defect concerns. 17 units distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall with no reported illnesses or injuries. The FDA Class II classification and voluntary nature indicate a manufacturing concern without confirmed patient harm.
Plain-English summary
Beaver Visitec International has voluntarily recalled BVI CustomEyes Procedure Packs due to the presence of syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Sol-M has undertaken a recall of low dead space and luer slip tip 1ml syringes due to manufacturing concerns.
The affected BVI CustomEyes Procedure Packs contain Sol-M syringes (Part Number 58001774, UDI-DI 30886158032886, Lot 6066202). Seventeen units were distributed nationwide.
Consumers and healthcare providers who have received these procedure packs should discontinue use and contact Beaver Visitec International for instructions regarding return or replacement.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001774;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- manufacturing-defect
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 (3)
- Part Number: 58001774
- UDI-DI: 30886158032886
- Lot/Batch Number: 6066202
Distribution
Distributed nationwide across the United States.
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