The Recall Desk
ModerateFDA (Devices)·Z-2924-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs recalled due to defective syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary manufacturer recall. The affected packs were distributed nationwide in the U.S.

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 with no reported illnesses, injuries, or deaths. The FDA Class II classification and lack of specified hazard details or adverse event reports support a moderate severity assessment per the rubric.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain 1ml syringes (both Luer Lock and Luer Slip types) manufactured by Sol-Millennium Medical, Inc. The recalled procedure packs are identified by Part Number 58001928 and Lot Number 6074346.

The recall is being conducted voluntarily due to an ongoing recall of the Sol-M manufactured syringes.

The affected procedure packs were distributed nationwide throughout the United States.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928;
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: 58001928
  • UDI-DI: 30886158033777
  • Lot/Batch Number: 6074346

Distribution

Distributed nationwide across the United States.