Medical Device Syringe Recall: BVI CustomEyes Procedure Packs
BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall. The recall affects 148 units distributed in the US.
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 an FDA Class II medical device with no reported illnesses or injuries. The recall rubric classifies voluntary precautionary recalls as Moderate severity.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. This is a voluntary recall.
The affected product (Part Number 58001200, Lot Number 6068518) consists of 148 units distributed nationwide in the United States. The syringes are identified by UDI-DI 30886158022757.
Healthcare providers and consumers who have obtained these procedure packs should contact Beaver Visitec International, Inc. for instructions regarding this recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001200;
- 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: 58001200
- UDI-DI: 30886158022757
- Lot/Batch Number: 6068518
Distribution
Distributed nationwide across the United States.
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