The Recall Desk
ModerateFDA (Devices)·Z-2911-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Nationwide for Syringe Defects

Beaver Visitec International has recalled 115 units of BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The voluntary recall addresses a manufacturing issue with the syringes included in the procedure packs.

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, precautionary recall of a Class II medical device with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (score 2).

Plain-English summary

Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58001764, Lot 6072080) that contain Sol-M Luer Lock and Luer Slip 1ml syringes. These syringes are manufactured by Sol-Millennium Medical (Sol-M), Inc., which has initiated a voluntary recall of these syringe models.

The affected procedure packs have been distributed nationwide in the United States. A total of 115 units are included in this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;
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: 58001764
  • UDI-DI: 30886158032435
  • Lot/Batch Number: 6072080

Distribution

Distributed nationwide across the United States.