The Recall Desk
ModerateFDA (Devices)·Z-2867-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) low dead space and luer slip tip 1ml syringes are being recalled due to a voluntary recall of these syringes.

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 Class II medical device recall. No illnesses, injuries, or specific hazard details are reported in the source material. Voluntary recalls without reported adverse events are classified as Moderate severity.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) Inc. low dead space and luer slip tip 1ml syringes (Part Number 58001394). The affected procedure packs are distributed nationwide in the United States.

Sol-M initiated a voluntary recall of these syringes. Because these syringes are incorporated into BVI CustomEyes Procedure Packs, Beaver Visitec International is issuing this recall of the complete procedure packs containing the affected syringes.

Healthcare facilities and professionals who have obtained or used these procedure packs may be affected. For specific instructions regarding the recall, affected parties should contact Beaver Visitec International, Inc. or refer to the FDA recall notice.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001394;
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: 58001394
  • UDI-DI: 30886158024041
  • Lot/Batch Number: 6071306

Distribution

Distributed nationwide across the United States.