The Recall Desk
ModerateFDA (Devices)·Z-2876-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes recalled

Beaver Visitec International recalls BVI CustomEyes Procedure Packs nationwide containing syringes from Sol-Millennium Medical's voluntary recall.

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 Class II FDA medical device recall with no reported injuries or illnesses. The recall is explicitly voluntary and precautionary in nature, matching the rubric criterion for Score 2: 'voluntary precautionary recalls.'

Plain-English summary

Beaver Visitec International has issued a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58001501) nationwide. The procedure packs contain 1ml syringes manufactured by Sol-Millennium Medical (Sol-M) in both low dead space and luer slip tip configurations. These syringes are subject to Sol-M's voluntary recall.

The affected lots are 6059497 and 6059849, representing 84 units in nationwide distribution.

Consumers and healthcare providers who have these procedure packs should contact Beaver Visitec International for further information regarding the recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;
Manufacturer
Beaver Visitec International, Inc.
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 (4)

  • Part Number: 58001501
  • UDI-DI: 30886158024171
  • Lot/Batch Number: 6059497
  • 6059849

Distribution

Distributed nationwide across the United States.