The Recall Desk
ModerateFDA (Devices)·Z-2842-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are subject to a voluntary recall. The recall affects 9 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 an FDA Class II recall with no reported illnesses or injuries and no stated hazard in the source text. It is characterized as a voluntary recall, which fits the 'voluntary precautionary recalls' criterion for a Moderate severity rating.

Plain-English summary

Beaver Visitec International, Inc. is issuing a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58001073) containing syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected packs contain low dead space Luer Lock and Luer Slip 1ml syringes.

The recall affects 9 units distributed nationwide in the United States. Affected products can be identified by Lot/Batch Number 6070760 and UDI-DI 30886158021934.

This is a voluntary recall of the Sol-M manufactured syringes by their maker. The specific reason for the recall is not provided in this notice.

Customers who have received these procedure packs are advised to contact Beaver Visitec International, Inc. or their supplier for further information and instructions regarding the recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001073;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • 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: 58001073
  • UDI-DI: 30886158021934
  • Lot/Batch Number: 6070760

Distribution

Distributed nationwide across the United States.