The Recall Desk
ModerateFDA (Devices)·Z-2874-2024·Announced 2024-09-04

Beaver Visitec recalls CustomEyes Procedure Packs with Sol-M syringes

Beaver Visitec International is voluntarily recalling 216 units of BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-M. The recall affects nationwide distribution.

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 medical device recall with voluntary nature. No specific hazard, defect, or adverse event reports are identified in the source notice. The rubric classifies voluntary precautionary recalls as Moderate (Score 2).

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs (Part Number 58001484) containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recall affects 216 units with lot numbers 6061631 and 6062125, distributed nationwide. The unique device identifier (UDI-DI) is 30886158024133.

This is a voluntary recall. The notice provided does not specify a hazard, defect, or adverse event associated with the affected syringes.

Healthcare professionals and facilities that have received these procedure packs should verify lot numbers against inventory to identify affected units. No further action guidance from the FDA or manufacturer is provided in the recall notice.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001484;
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 (4)

  • Part Number: 58001484
  • UDI-DI: 30886158024133
  • Lot/Batch Number: 6061631
  • 6062125

Distribution

Distributed nationwide across the United States.