The Recall Desk
ModerateFDA (Devices)·Z-2887-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Defective Syringes

BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been 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 voluntary, precautionary Class II medical device recall with no reported injuries, illnesses, or deaths. The specific hazard is not detailed in the source material.

Plain-English summary

BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M) are subject to a voluntary recall. The affected packs contain Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number 58001602.

A total of 97 procedure packs have been distributed to customers nationwide. The recalled products are identified by Part Number 58001602, UDI-DI 30886158032060, and Lot Number 6064637.

Customers in possession of the recalled procedure packs should discontinue use and contact BVI CustomEyes for replacement or instructions regarding their recalled units.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;
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: 58001602
  • UDI-DI: 30886158032060
  • Lot/Batch Number: 6064637

Distribution

Distributed nationwide across the United States.