The Recall Desk
ModerateFDA (Devices)·Z-2850-2024·Announced 2024-09-04

Medical Syringes in BVI CustomEyes Procedure Packs Recalled

BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. The recall involves 315 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 Class II voluntary recall with no reported illnesses or injuries mentioned in the source. The specific defect is not detailed, indicating a precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. has voluntarily recalled BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The recall was initiated due to Sol-M's voluntary recall of these syringes.

The recalled procedure packs include 315 units with Part Number 58001176 (UDI-DI: 30886158022443, Lot Number: 6069393). The affected product was distributed nationwide in the United States.

Consumers and healthcare facilities that received the affected procedure packs should contact Beaver Visitec International for instructions on handling the recalled product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001176;
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: 58001176
  • UDI-DI: 30886158022443
  • Lot/Batch Number: 6069393

Distribution

Distributed nationwide across the United States.