The Recall Desk
ModerateFDA (Devices)·Z-2862-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

BVI CustomEyes Procedure Packs are being recalled because they contain Sol-Millennium Medical syringes that were voluntarily recalled by the manufacturer. The affected packs were 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 Class II medical device recall issued on a voluntary basis with no reported illnesses, injuries, or deaths. The rubric explicitly identifies voluntary precautionary recalls as Moderate severity.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes are being recalled. The syringes, manufactured by Sol-Millennium Medical (Sol-M), were the subject of a voluntary recall by the manufacturer.

The affected procedure packs have been distributed nationwide in the United States. The recalled packs are identified by Part Number 58001374 and UDI-DI 30886158031926, with Lot/Batch Number 6062022. Approximately 306 units are impacted.

Consumers who have received these procedure packs should stop using them and contact Beaver Visitec International, Inc., the recalling firm, for instructions on return or replacement.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001374;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • syringe-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: 58001374
  • UDI-DI: 30886158031926
  • Lot/Batch Number: 6062022

Distribution

Distributed nationwide across the United States.