The Recall Desk
ModerateFDA (Devices)·Z-2926-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes recalled

Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes 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 Class II FDA recall with no reported illnesses, injuries, or deaths. The source does not specify the underlying hazard, indicating this is a precautionary measure rather than a response to actual harm.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) manufactured syringes are being voluntarily recalled. The affected syringes are low dead space and luer slip tip models with Part Number 58001934, UDI-DI 30886158033562, and Lot Number 6070801. A total of 102 units were distributed nationwide.

The recall was initiated by Beaver Visitec International, Inc., the manufacturer of the procedure packs. The specific reason for the recall is not detailed in the public announcement.

Consumers and healthcare facilities who have received this product should discontinue use and contact Beaver Visitec International for further instructions regarding return or disposal of the affected procedure packs.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;
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: 58001934
  • UDI-DI: 30886158033562
  • Lot/Batch Number: 6070801

Distribution

Distributed nationwide across the United States.