BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary recall by the syringe manufacturer. The recall affects 43 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: This is a voluntary recall of medical device components with no reported illnesses, injuries, or specific hazards articulated in the source. The FDA Class II classification with no reported adverse events supports a Moderate severity rating per the rubric criterion for voluntary precautionary recalls.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. (Part Number 58001138, Lot 6064069). The recall affects approximately 43 units that were distributed nationwide.
The procedure packs contain low dead space and luer slip tip model syringes. These syringes are subject to a voluntary recall initiated by their manufacturer, Sol-M, Inc.
Customers and healthcare providers who have received these procedure packs should contact Beaver Visitec International, Inc. for instructions regarding the recall and management of affected products.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- 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: 58001138
- UDI-DI: 30886158022320
- Lot/Batch Number: 6064069
Distribution
Distributed nationwide across the United States.
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