The Recall Desk
ModerateFDA (Devices)·Z-2785-2024·Announced 2024-09-04

BVI Voluntarily Recalls CustomEyes Procedure Packs Containing Sol-M Syringes

BVI is voluntarily recalling CustomEyes Procedure Packs that contain Sol-M manufactured syringes. The affected products were distributed nationwide in the United States.

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 or injuries. The voluntary nature of the recall and lack of adverse event reports place it in the Moderate category per the severity rubric.

Plain-English summary

Beaver Visitec International is recalling CustomEyes Procedure Packs due to the inclusion of low dead space and luer slip tip 1ml syringes manufactured by Sol-Millennium Medical, Inc. These procedure packs (Part Number 584587, UDI-DI 30886158141083, Lot/Batch 6071014) were distributed nationwide in the United States, with 49 units affected.

The recall is a voluntary action undertaken by BVI relating to the Sol-M manufactured syringe components supplied in these procedure packs.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584587;
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: 584587
  • UDI-DI: 30886158141083
  • Lot/Batch Number: 6071014

Distribution

Distributed nationwide across the United States.