The Recall Desk
ModerateFDA (Devices)·Z-2918-2024·Announced 2024-09-04

CustomEyes Procedure Packs with Sol-M Syringes Recalled by Beaver Visitec International

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs (Lot 6066752) containing Sol-M syringes. Approximately 22 units distributed nationwide in the US have been affected.

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 voluntary FDA Class II recall with no reported illnesses or injuries. The source does not detail a specific hazard associated with the Sol-M syringes. The recall is precautionary in nature, fitting the 'voluntary precautionary recalls' category, which corresponds to a Moderate severity score.

Plain-English summary

Beaver Visitec International, Inc. (BVI) is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001836, Lot Number 6066752) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc.

Approximately 22 units of the affected procedure packs have been distributed nationwide in the United States. The packs are used in ophthalmic surgical procedures.

This voluntary recall of the procedure packs was initiated in response to the voluntary recall of the Sol-M syringes contained within them.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001836;
Manufacturer
Beaver Visitec International, Inc.

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: 58001835
  • UDI-DI: 30886158032985
  • Lot/Batch Number: 6066752

Distribution

Distributed nationwide across the United States.