The Recall Desk
ModerateFDA (Devices)·Z-2883-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes in a voluntary manufacturer recall. 238 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 voluntary recall with no reported illnesses or injuries. The rubric specifically identifies voluntary precautionary recalls as Moderate severity.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs (Part Number 58001546) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. This is a voluntary recall at the manufacturer's request.

238 units of the affected procedure packs were distributed nationwide in the United States. The affected products are identified by Part Number 58001546 and Lot/Batch Number 6069646. Consumers and healthcare facilities that have received these procedure packs should stop using them and contact Beaver Visitec International for further instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001546;
Manufacturer
Beaver Visitec International, Inc.

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: 58001546
  • UDI-DI: 30886158031703
  • Lot/Batch Number: 6069646

Distribution

Distributed nationwide across the United States.