The Recall Desk
ModerateFDA (Devices)·Z-2821-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled. The recall affects 840 units 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 recall of FDA Class II medical devices with no reported illnesses or injuries, consistent with precautionary recalls rather than response to documented harm.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) low dead space and luer slip tip 1ml syringes (Part Number 58000757) are subject to a voluntary recall.

A total of 840 units with lot/batch numbers 6069002 and 6071184 have been distributed nationwide in the United States. The procedure packs are manufactured and distributed by Beaver Visitec International, Inc.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000757;
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 (4)

  • Part Number: 58000757
  • UDI-DI: 30886158020265
  • Lot/Batch Number: 6069002
  • 6071184

Distribution

Distributed nationwide across the United States.