The Recall Desk
ModerateFDA (Devices)·Z-2848-2024·Announced 2024-09-04

FDA Recalls Sol-M Syringes in BVI CustomEyes Procedure Packs

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes following a voluntary recall initiated by syringe manufacturer Sol-Millennium Medical (Sol-M), Inc.

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 a medical device classified by the FDA as Class II. No illnesses, injuries, or deaths have been reported, and the specific hazard is not detailed in the recall notice, making it a theoretical risk. Voluntary precautionary recalls of this type are classified as Moderate severity per the rubric.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001157) are subject to a voluntary recall initiated by Sol-Millennium Medical (Sol-M), Inc., the syringe manufacturer.

The affected procedure packs have been distributed nationwide in the U.S. The affected lot number is 6065072, with 24 units identified in this recall.

This recall is FDA classified as Class II. The specific reason for the recall is not detailed in the recall notice. Consumers who have received these procedure packs should contact Beaver Visitec International or the recalling firm for information regarding return or replacement of the affected products.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001157;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Syringes
Affected units
24

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: 58001157
  • UDI-DI: 30886158022931
  • Lot/Batch Number: 6065072

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 159 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 159 products in this recall →

Related recalls

Same manufacturer · Beaver Visitec International, Inc.

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