FDA Recalls BVI CustomEyes Procedure Packs Containing Sol-M Syringes
The FDA has issued a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. Approximately 8 units have been 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 Class II medical device recall with voluntary status. No patient illnesses, injuries, or deaths are reported in the source, and the specific hazard is not detailed.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58000921, Lot 6073120) are subject to a voluntary recall. The recall involves syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. that are present in some BVI CustomEyes Procedure Packs.
Approximately 8 units of the affected product have been distributed nationwide. The specific reason for the recall is not detailed in the agency announcement.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000921;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- device-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: 58000921
- UDI-DI: 30886158021309
- Lot/Batch Number: 6073120
Distribution
Distributed nationwide across the United States.
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