BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 584545) nationwide. The recall is voluntary.
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: FDA Class II device subject to a voluntary recall with no specified hazard or reported illnesses/injuries. Per the recall severity rubric, voluntary precautionary recalls without stated adverse events score as Moderate.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled nationwide. The affected product (Part Number 584545, Lot Number 6074344, UDI-DI: 30886158140710) contains low dead space and luer slip tip 1 ml syringes manufactured by Sol-Millennium Medical, Inc.
This is a voluntary recall of the syringes included in the CustomEyes Procedure Packs. The source documentation does not specify the underlying reason for the Sol-M syringe recall. The product was distributed throughout the United States, affecting 18 units.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584545;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 18
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: 584545
- UDI-DI: 30886158140710
- Lot/Batch Number: 6074344
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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