Voluntary Recall of BVI CustomEyes Procedure Packs with Sol-M Syringes
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. The affected packs were 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 FDA Class II medical device recall involves no reported illnesses, injuries, or deaths. As a voluntary precautionary recall without documented adverse events, it meets the criteria for Moderate severity.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The recalled product contains Sol-M Luer Lock and Luer Slip 1ml syringes, identified by Part Number 58001609 and Lot Number 6064451.
Approximately 82 units of these procedure packs have been distributed throughout the United States. The specific hazard or reason for the recall has not been detailed in the recall notice. This is a voluntary recall conducted by the manufacturer.
Consumers and healthcare facilities who have received or used these recalled procedure packs should contact Beaver Visitec International for instructions on how to proceed with the affected product.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
- 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: 58001609
- UDI-DI: 30886158031544
- Lot/Batch Number: 6064451
Distribution
Distributed nationwide across the United States.
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