The Recall Desk
ModerateFDA (Devices)·Z-2831-2024·Announced 2024-09-04

Voluntary Recall of BVI CustomEyes Procedure Packs with Sol-M Syringes

Beaver Visitec International is voluntarily recalling 1,429 units of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. 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 is a Class II voluntary recall with no reported illnesses or injuries. Voluntary precautionary recalls without reported adverse effects are classified as Moderate per the FDA severity rubric.

Plain-English summary

Beaver Visitec International, Inc. is recalling 1,429 units of BVI CustomEyes Procedure Packs (Part Number 58000873) containing low dead space and luer slip tip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected lot numbers are 6062129 and 6074045.

This is a voluntary recall. The FDA announcement does not specify the reason for the recall. The CustomEyes Procedure Packs have been distributed nationwide in the United States.

Healthcare providers and facilities that have received these procedure packs should stop using them. Contact Beaver Visitec International or the FDA for instructions regarding product return or disposal.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000873;
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 (4)

  • Part Number: 58000873
  • UDI-DI: 30886158020807
  • Lot/Batch Number: 6062129
  • 6074045

Distribution

Distributed nationwide across the United States.