The Recall Desk
ModerateFDA (Devices)·Z-2846-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

Beaver Visitec International is recalling 1,238 units of BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall is voluntary and affects procedure packs distributed nationwide.

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 Class II FDA medical device recall has no reported injuries or illnesses and is described as voluntary. Voluntary precautionary recalls without incident reports are classified as Moderate severity.

Plain-English summary

Beaver Visitec International, Inc. is recalling 1,238 units of BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001123). These procedure packs are distributed nationwide and are used in ophthalmologic procedures.

The affected procedure packs contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc., which initiated a voluntary recall. The specific lots affected are 6047610, 6049448, and 6050478 (UDI-DI: 30886158022467).

If you have these procedure packs, contact Beaver Visitec International, Inc. for further 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: 58001123;
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 (5)

  • Part Number: 58001123
  • UDI-DI: 30886158022467
  • Lot/Batch Number: 6047610
  • 6049448
  • 6050478

Distribution

Distributed nationwide across the United States.