BVI CustomEyes Procedure Packs with Sol-M syringes recalled
Beaver Visitec International is voluntarily recalling 82 units of CustomEyes Procedure Packs containing Sol-M syringes due to a manufacturer recall. Affected lot numbers 6070885 and 6074819.
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: FDA Class II recall with no reported illnesses or injuries. The source describes this as a voluntary precautionary recall initiated by the syringe manufacturer, with no specific hazard details provided.
Plain-English summary
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recall is voluntary and initiated due to a manufacturer recall of these syringes.
The affected product includes 82 units distributed nationwide. The lot/batch numbers involved are 6070885 and 6074819, with Part Number 58001711.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001711;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 82
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 (4)
- Part Number: 58001711
- UDI-DI: 30886158032442
- Lot/Batch Number: 6070885
- 6074819
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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