The Recall Desk
ModerateFDA (Devices)·Z-2897-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntarily Recalled

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical low dead space and luer slip tip syringes. The recall affects 141 units 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 recall with no reported illnesses, injuries, or hospitalizations documented in the source. Although classified as FDA Class II, the voluntary nature and absence of adverse events align with the rubric criterion for voluntary precautionary recalls, which are scored Moderate (2).

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001637) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. The recall affects 141 units that were distributed nationwide in the United States.

The affected procedure packs are identified by Lot/Batch Number 6064640 and UDI-DI 30886158031858. This is FDA recall number Z-2897-2024.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001637;
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: 58001637
  • UDI-DI: 30886158031858
  • Lot/Batch Number: 6064640

Distribution

Distributed nationwide across the United States.