The Recall Desk
ModerateFDA (Devices)·Z-2824-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The recall affects 489 units distributed nationwide.

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 an FDA Class II voluntary recall with no hazard explicitly stated in the source documentation and no reported illnesses, injuries, or failures. Voluntary precautionary recalls without reported incidents are classified as Moderate per the rubric.

Plain-English summary

BVI CustomEyes Procedure Packs (Part Number 58000781) are being voluntarily recalled by Beaver Visitec International. These procedure packs contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected lot numbers are 6056022 and 6067191, with 489 units identified for this recall. Distribution was nationwide in the United States.

The source documentation does not specify the particular defect or hazard prompting the recall beyond noting that Sol-M syringes present in the BVI CustomEyes Procedure Packs are subject to a voluntary recall by the manufacturer.

Healthcare facilities and medical professionals in possession of affected BVI CustomEyes Procedure Packs should verify lot numbers against those listed and may wish to contact Beaver Visitec International for guidance on appropriate handling of the recalled product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000781;
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: 58000781
  • UDI-DI: 30886158020333
  • Lot/Batch Number: 6056022
  • 6067191

Distribution

Distributed nationwide across the United States.