BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by the syringe manufacturer. The affected packs 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: FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The recall is voluntary in nature, meeting the rubric criterion for a Moderate (2) severity level. No specific hazard or adverse health effects have been disclosed, and the precautionary character of the recall supports this classification.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58001380, Lot 6071744) due to a voluntary recall of syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The affected procedure packs contain Sol-M syringes with Luer Lock and Luer Slip tips in 1ml configuration.
The recalled procedure packs have been distributed nationwide across the United States. The specific reason for the voluntary recall initiated by the syringe manufacturer has not been disclosed in available communications.
Consumers and healthcare facilities using these procedure packs should stop use and contact Beaver Visitec International, Inc. for instructions on replacement products and proper handling of affected units.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001380;
- Manufacturer
- Beaver Visitec International, Inc.
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: 58001380
- UDI-DI: 30886158023846
- Lot/Batch Number: 6071744
Distribution
Distributed nationwide across the United States.
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