BVI CustomEyes Procedure Packs with Defective Syringes Recalled Nationwide
BVI CustomEyes Procedure Packs containing Sol-M syringes are being voluntarily recalled due to a defect in the syringes.
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 an FDA Class II voluntary recall initiated following the syringe manufacturer's own recall. No specific hazard details or illnesses/injuries are reported, consistent with a precautionary measure.
Plain-English summary
BVI CustomEyes Procedure Packs are being voluntarily recalled. These packs contain 1ml syringes (Luer Lock and Luer Slip types) manufactured by Sol-Millennium Medical (Sol-M), Inc.
BVI initiated this recall in response to a voluntary recall by Sol-M, the syringe manufacturer. The syringes included in these procedure packs are the subject of the manufacturer's recall.
The affected procedure packs have been distributed nationwide in the United States.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001304;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device
- Hazard
- syringe-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: 58001304
- UDI-DI: 30886158023778
- Lot/Batch Number: 6069386
Distribution
Distributed nationwide across the United States.
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