The Recall Desk
ModerateFDA (Devices)·Z-2896-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Recalled Sol-M Syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., subject to a voluntary recall by the manufacturer.

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 FDA recall with no reported illnesses or hospitalizations. The recall is voluntary and prompted by the manufacturer's recall of the syringes, consistent with the rubric category of voluntary precautionary recalls.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number 58001635. These syringes are manufactured by Sol-Millennium Medical, Inc. and are subject to a voluntary recall by the manufacturer.

The affected procedure packs were distributed nationwide across the United States. The recall involves 444 units with lot/batch numbers 6063185 and 6067384.

The specific reason for Sol-Millennium Medical's recall of these syringes is not provided in this notice.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
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: 58001635
  • UDI-DI: 30886158031681
  • Lot/Batch Number: 6063185
  • 6067384

Distribution

Distributed nationwide across the United States.