The Recall Desk
ModerateFDA (Devices)·Z-2936-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 104 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 a voluntary precautionary recall of a Class II medical device with no reported illnesses, injuries, or deaths. Per the severity rubric, voluntary precautionary recalls without reported harm are classified as Moderate.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Specifically, the procedure packs contain Sol-M low dead space and luer slip tip 1ml syringes.

This is a voluntary recall. A total of 104 units have been distributed nationwide in the United States.

The affected products are identified by Part Number 58002074 and Lot/Batch Number 6074312 (UDI-DI: 30886158034484). Healthcare providers and facilities that have received these procedure packs should stop using them and contact Beaver Visitec International for replacement units or further instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002074;
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: 58002074
  • UDI-DI: 30886158034484
  • Lot/Batch Number: 6074312

Distribution

Distributed nationwide across the United States.