The Recall Desk
ModerateFDA (Devices)·Z-2880-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs With Sol-M Syringes Recalled Voluntarily

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical due to a voluntary recall by the syringe 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 an FDA Class II recall initiated voluntarily by the manufacturer. No illnesses, injuries, or deaths are reported in the source material. Voluntary precautionary recalls without reported adverse events are classified as Moderate per the severity rubric.

Plain-English summary

BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are being recalled. The affected packs are identified by Part Number 58001526 (UDI-DI 30886158031476, Lot 6070130) and have been distributed nationwide in the United States.

Beaver Visitec International, Inc. initiated this voluntary recall following a recall of the component syringes by their manufacturer, Sol-Millennium Medical.

Healthcare facilities using these packs should contact Beaver Visitec International, Inc. for information and instructions regarding this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001526;
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: 58001526
  • UDI-DI: 30886158031476
  • Lot/Batch Number: 6070130

Distribution

Distributed nationwide across the United States.