The Recall Desk
ModerateFDA (Devices)·Z-2906-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) syringes, affecting 126 units distributed nationwide. The recall was initiated following a manufacturer recall of the syringe components.

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 recall with no reported illnesses or injuries. The recall was initiated voluntarily by the manufacturer in response to a syringe manufacturer recall, fitting the criterion for voluntary precautionary recalls.

Plain-English summary

Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58001712, Lot 6074820, UDI-DI: 30886158032428) that contain low dead space and Luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The FDA has classified this as a Class II recall. A total of 126 units were distributed throughout the United States.

The recall was initiated by Beaver Visitec International in response to a recall of these syringes by their manufacturer, Sol-Millennium Medical, Inc.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001712;
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: 58001712
  • UDI-DI: 30886158032428
  • Lot/Batch Number: 6074820

Distribution

Distributed nationwide across the United States.