The Recall Desk
ModerateFDA (Devices)·Z-2782-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 247 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 reported illnesses, injuries, or hospitalizations. Voluntary precautionary recalls without known harm are classified as Moderate per the severity rubric.

Plain-English summary

BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are being recalled. The affected products include Sol-M low dead space syringes and luer slip tip syringes (Part Number 584404). A total of 247 units were distributed nationwide in the United States.

This is a voluntary recall. The recalled syringes are contained within BVI CustomEyes Procedure Packs and are identified by UDI-DI 30886158141151 and Lot/Batch Number 6071194.

Healthcare providers and facilities that have received these procedure packs should contact Beaver Visitec International, Inc. for further information and instructions regarding the recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584404;
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 (3)

  • Part Number: 584404
  • UDI-DI: 30886158141151
  • Lot/Batch Number: 6071194

Distribution

Distributed nationwide across the United States.