The Recall Desk
ModerateFDA (Devices)·Z-2816-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing Sol-M syringes recalled nationwide

Procedure packs containing Sol-M manufactured syringes are being voluntarily recalled nationwide. The affected product is part number 58000603.

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 voluntary recall with no reported illnesses or injuries. The voluntary precautionary nature and absence of any reported harm incidents place this in the Moderate category per the recall severity rubric, which explicitly identifies voluntary precautionary recalls as Moderate severity.

Plain-English summary

BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are subject to a voluntary recall. The affected procedure packs contain Luer Lock and Luer Slip 1ml syringes (Part Number 58000603, Lot Number 6069800).

The recall was initiated due to concerns with the Sol-M manufactured syringes included in these procedure packs. The procedure packs have been distributed nationwide in the United States, affecting 54 units.

Individuals or organizations that have received these BVI CustomEyes Procedure Packs should check their inventory to determine if they possess the recalled product. Those who have the affected procedure packs should contact Beaver Visitec International, Inc. for further instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000603;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • medical-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: 58000603
  • UDI-DI: 30886158019436
  • Lot/Batch Number: 6069800

Distribution

Distributed nationwide across the United States.