The Recall Desk
ModerateFDA (Devices)·Z-2840-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Issue

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, which are subject to a separate voluntary recall.

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 recall of FDA Class II medical devices with no reported illnesses, injuries, or specific hazard explanation provided in the source text. Voluntary precautionary recalls without evidence of reported harm are classified as Moderate.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001048, Lot 6069190) that contain 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recall was initiated because the syringes supplied by Sol-M are the subject of a separate voluntary recall.

The affected procedure packs were distributed nationwide in the United States. These packs contain both Sol-M Luer Lock and Luer Slip 1ml syringes.

Healthcare providers and consumers who have received these procedure 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: 58001048;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • 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: 58001048
  • UDI-DI: 30886158022344
  • Lot/Batch Number: 6069190

Distribution

Distributed nationwide across the United States.