The Recall Desk
ModerateFDA (Devices)·Z-2783-2024·Announced 2024-09-04

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
  • syringe-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: 584545
  • UDI-DI: 30886158140710
  • Lot/Batch Number: 6074344

Distribution

Distributed nationwide across the United States.