The Recall Desk
ModerateFDA (Devices)·Z-2938-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs recalled for Sol-M syringe components

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes with low dead space and luer slip tip configurations. The product was 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 is a voluntary precautionary recall with no reported illnesses or injuries. Although classified as FDA Class II, the absence of hospitalization reports and explicit hazard description prevents escalation beyond Moderate per the recall rubric.

Plain-English summary

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The recalled procedure packs contain low dead space and luer slip tip 1ml syringes with Part Number 58002078, Lot/Batch Number 6074316, and UDI-DI 30886158034521.

The affected product was distributed nationwide throughout the United States, affecting approximately 160 units. This recall is designated as FDA Recall Z-2938-2024 and is classified as a Class II recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078;
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: 58002078
  • UDI-DI: 30886158034521
  • Lot/Batch Number: 6074316

Distribution

Distributed nationwide across the United States.