The Recall Desk
ModerateFDA (Devices)·Z-2811-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs recalled for syringe manufacturing defect

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected procedure packs contain low dead space Luer Lock and Luer Slip 1ml syringes 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 Class II recall with no reported illnesses, injuries, or deaths. The source explicitly describes it as a voluntary precautionary action, which per the severity rubric classifies as Moderate.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The procedure packs contain Sol-M low dead space Luer Lock and Luer Slip 1ml syringes with Part Number 58000501 and Lot Number 6073086.

23 units of these procedure packs were distributed nationwide throughout the United States. The recall is due to the presence of syringes manufactured by Sol-M with the specified characteristics.

Consumers and healthcare providers who have received these procedure packs should cease use and contact Beaver Visitec International, Inc. for information on the recall and replacement or return procedures.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000501;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • syringe-defect
  • manufacturing-issue

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: 58000501
  • UDI-DI: 30886158019085
  • Lot/Batch Number: 6073086

Distribution

Distributed nationwide across the United States.