The Recall Desk
ModerateFDA (Devices)·Z-2822-2024·Announced 2024-09-04

BVI CustomEyes Procedure Pack Syringes Voluntarily Recalled Nationwide

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M Inc. due to a voluntary manufacturer recall of certain syringe types 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: Voluntary recall with no reported illnesses or injuries disclosed in the source material. Although FDA Class II designation indicates a potential hazard, the absence of reported harm and the voluntary nature of the recall classify this as a moderate-severity precautionary measure.

Plain-English summary

Beaver Visitec International, Inc. (BVI) is voluntarily recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected product is identified by Part Number 58000759, with Lot Number 6050813 and UDI-DI 30886158020302.

The recalled procedure packs have been distributed nationwide in the United States.

Consumers and healthcare facilities who have received these procedure packs should stop using the affected product immediately and contact their healthcare provider or distributor for instructions on replacement or return of the recalled product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000759;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • device-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: 58000759
  • UDI-DI: 30886158020302
  • Lot/Batch Number: 6050813

Distribution

Distributed nationwide across the United States.