The Recall Desk
ModerateFDA (Devices)·Z-2929-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

Beaver Visitec International has voluntarily recalled BVI CustomEyes Procedure Packs that contain Sol-Millennium Medical syringes following a concurrent recall of those syringes. The packs 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 recall is classified as FDA Class II with no reported illnesses, injuries, or deaths. The voluntary nature of the recall and absence of reported harm support a moderate severity rating.

Plain-English summary

Beaver Visitec International, Inc. (BVI) is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The affected product is identified by Part Number 58001967, with the specific recalled lot being Lot Number 6074600. These procedure packs were distributed nationwide throughout the United States.

The recall is being issued due to a concurrent voluntary recall of the Sol-M syringes that are included in these procedure packs. No specific hazard has been publicly detailed in this recall notice.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001967;
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: 58001967
  • UDI-DI: 30886158033715
  • Lot/Batch Number: 6074600

Distribution

Distributed nationwide across the United States.