The Recall Desk
ModerateFDA (Devices)·Z-2856-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs With Sol-M Syringes Voluntarily Recalled

Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs (Part Number 58001306, Lot 6072093) containing Sol-M manufactured syringes. The recall affects 206 units distributed nationwide due to a voluntary recall by the syringe manufacturer.

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: FDA Class II voluntary recall with no reported illnesses or injuries. The severity rubric designates voluntary precautionary recalls as Moderate (Score 2).

Plain-English summary

Beaver Visitec International, Inc. has voluntarily recalled BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1 milliliter syringes (Part Number: 58001306, Lot Number: 6072093). The affected lot comprises 206 units distributed nationwide in the United States.

The recall is due to a voluntary recall initiated by Sol-Millennium Medical, Inc., the manufacturer of the syringes. These syringes are included as component items in Beaver Visitec's CustomEyes Procedure Packs.

Customers and healthcare practitioners who have obtained BVI CustomEyes Procedure Packs with this lot number should discontinue use and contact Beaver Visitec International for instructions regarding return or replacement of the affected product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001306;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • 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 (3)

  • Part Number: 58001306
  • UDI-DI: 30886158023754
  • Lot/Batch Number: 6072093

Distribution

Distributed nationwide across the United States.