The Recall Desk
ModerateFDA (Devices)·Z-2855-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntarily Recalled

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled 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 Class II medical device recall with no reported illnesses, injuries, or deaths in the source material. Per the severity rubric, voluntary precautionary recalls are classified as Moderate.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain certain Sol-M Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical, Inc. These syringes are incorporated as components in some BVI CustomEyes Procedure Packs.

The recall affects 46 units distributed nationwide in the United States. The affected procedure packs are identified by Part Number 58001305, UDI-DI 30886158023761, and Lot Number 6070642.

Healthcare providers and customers in possession of these procedure packs should discontinue use immediately. For questions regarding the recall or to arrange return or replacement of affected units, contact Beaver Visitec International.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001305;
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: 58001305
  • UDI-DI: 30886158023761
  • Lot/Batch Number: 6070642

Distribution

Distributed nationwide across the United States.