The Recall Desk
ModerateFDA (Devices)·Z-2815-2024·Announced 2024-09-04

Voluntary Recall of BVI CustomEyes Procedure Packs with Sol-M Syringes

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58000594, Lot 6073112) containing Sol-M manufactured 1 milliliter syringes due to a recall of those syringes by their manufacturer.

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 Class II medical device recall of a voluntary nature. No illnesses, injuries, or deaths have been reported. The specific hazard details are not provided in the source material.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1 milliliter syringes (Part Number 58000594). The affected lot is 6073112, with 76 units distributed nationwide in the United States.

Sol-Millennium Medical, Inc. (Sol-M), the manufacturer of these syringes, has issued a recall for the syringes contained in these procedure packs. The specific reason for Sol-M's recall is not detailed in this notice.

Customers and healthcare facilities that have received these procedure packs should discontinue use and contact Beaver Visitec International, Inc. for instructions regarding 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: 58000594;
Manufacturer
Beaver Visitec International, Inc.

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: 58000594
  • UDI-DI: 30886158019948
  • Lot/Batch Number: 6073112

Distribution

Distributed nationwide across the United States.