BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Components
BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall. The recall affects 45 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: FDA Class II voluntary precautionary recall. No specific hazard or illnesses are described in the source. Classified as Moderate per the rubric criterion for voluntary precautionary recalls, rather than Low, due to the medical device classification and Class II status.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes are subject to a voluntary recall. The procedure packs are manufactured by Beaver Visitec International, Inc. and contain syringe components produced by Sol-Millennium Medical (Sol-M), Inc. The recalled product is identified by Part Number 58000477 and Lot Number 6072535.
The affected packs have been distributed nationwide throughout the United States. A total of 45 units are included in this recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000477;
- 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: 58000477
- UDI-DI: 30886158019115
- Lot/Batch Number: 6072535
Distribution
Distributed nationwide across the United States.
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