The Recall Desk
ModerateFDA (Devices)·Z-2899-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is voluntarily recalling 4,301 units of BVI CustomEyes Procedure Packs containing Sol-Millennium Medical 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 Class II medical device recall with no reported illnesses or injuries. The recall is explicitly described as voluntary and precautionary in nature, fitting the Moderate severity category.

Plain-English summary

The recall covers BVI CustomEyes Procedure Packs (Part Number 58001658) that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Specifically, the packs contain low dead space syringes and luer slip tip syringes. The recall affects 4,301 units distributed nationwide in the United States.

The affected lot numbers are 6063718, 6065086, 6067685, and 6073791. The UDI-DI (Unique Device Identification) for these products is 30886158032091. Beaver Visitec International, Inc. is the firm conducting this voluntary recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001658;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • medical-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 (6)

  • Part Number: 58001658
  • UDI-DI: 30886158032091
  • Lot/Batch Number: 6063718
  • 6065086
  • 6067685
  • 6073791

Distribution

Distributed nationwide across the United States.