The Recall Desk
ModerateFDA (Devices)·Z-2901-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Defective Syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes due to a manufacturer's voluntary recall. The nationwide recall affects Luer Lock and Luer Slip 1ml syringes in the procedure packs.

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: FDA Class II voluntary recall with no reported injuries or illnesses and no specific hazard described in the source material. This qualifies as a voluntary precautionary recall per the severity rubric.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Specifically, the recalled packs contain Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001693) distributed nationwide.

This recall is due to a voluntary recall of the Sol-M syringes by the manufacturer. The affected product has Lot Number 6062795 and UDI-DI 30886158031971.

Healthcare providers and facilities using these procedure packs should verify whether they have the recalled lot in their inventory. Contact Beaver Visitec International for instructions on return or replacement of the affected packs.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001693;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • defective-component

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: 58001693
  • UDI-DI: 30886158031971
  • Lot/Batch Number: 6062795

Distribution

Distributed nationwide across the United States.