The Recall Desk
ModerateFDA (Devices)·Z-2861-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. The recall affects 876 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, precautionary recall with no reported illnesses or injuries. The specific defect is not disclosed in the source. FDA Class II recalls without reported hospitalization or injury reports typically merit a Moderate severity score.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001373) that contain low dead space and luer slip 1ml syringes manufactured by Sol-Millennium Medical, Inc.

The recall involves 876 units that were distributed nationwide. The affected product can be identified by lot numbers 6058442 and 6064858. The product's UDI-DI is 30886158024386.

This is a voluntary recall of the syringes manufactured by Sol-Millennium Medical, Inc., which are present in some BVI CustomEyes Procedure Packs.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001373;
Manufacturer
Beaver Visitec International, Inc.

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 (4)

  • Part Number: 58001373
  • UDI-DI: 30886158024386
  • Lot/Batch Number: 6058442
  • 6064858

Distribution

Distributed nationwide across the United States.