BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International is voluntarily recalling 4,301 units of BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Class II medical device recall with no reported illnesses or injuries. The recall is explicitly described as voluntary and precautionary in nature, fitting the Moderate severity category.
Plain-English summary
The recall covers BVI CustomEyes Procedure Packs (Part Number 58001658) that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Specifically, the packs contain low dead space syringes and luer slip tip syringes. The recall affects 4,301 units distributed nationwide in the United States.
The affected lot numbers are 6063718, 6065086, 6067685, and 6073791. The UDI-DI (Unique Device Identification) for these products is 30886158032091. Beaver Visitec International, Inc. is the firm conducting this voluntary recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001658;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 4,301
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 (6)
- Part Number: 58001658
- UDI-DI: 30886158032091
- Lot/Batch Number: 6063718
- 6065086
- 6067685
- 6073791
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 159 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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