The Recall Desk
ModerateFDA (Devices)·Z-2928-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by their manufacturer. Approximately 332 units were 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 a Class II medical device recall involving syringes. The recall is voluntary with no reported illnesses, injuries, or deaths, and no specific hazard is identified in the notice. Per the FDA severity rubric, voluntary precautionary recalls are typically classified as Moderate.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing 1ml syringes with Luer Lock and Luer Slip tips manufactured by Sol-Millennium Medical (Sol-M), Inc., Part Number 58001944, Lot 6070908. Approximately 332 units were distributed nationwide in the United States.

The recall is voluntary and is initiated because these syringes are subject to a recall by their manufacturer, Sol-Millennium Medical, Inc. The specific defect prompting the manufacturer's recall is not detailed in this announcement.

Consumers and healthcare providers should contact Beaver Visitec International for instructions regarding these recalled procedure packs.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
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: 58001944
  • UDI-DI: 30886158033630
  • Lot/Batch Number: 6070908

Distribution

Distributed nationwide across the United States.