BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The affected units 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 is a voluntary precautionary recall of a medical device (FDA Class II) with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M syringes (Part Number 58001527, Lot Number 6071514) are subject to a voluntary recall by Beaver Visitec International, Inc. These procedure packs contain 1ml Luer Lock and Luer Slip syringes manufactured by Sol-Millennium Medical, Inc. with low dead space configurations.
The recall affects procedure packs distributed nationwide. Consumers who have received these procedure packs should contact Beaver Visitec International, Inc. or their supplier for further information and instructions regarding the recalled product.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001527;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device
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: 58001527
- UDI-DI: 30886158031483
- Lot/Batch Number: 6071514
Distribution
Distributed nationwide across the United States.
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