The Recall Desk
ModerateFDA (Devices)·Z-2877-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Voluntary Recall for Sol-M Syringes

Beaver Visitec is voluntarily recalling CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical that were subject to a manufacturer recall. A total of 66 units were 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 an FDA Class II device recall with no reported illnesses or injuries. The recall is described as voluntary, and the specific nature of the defect is not detailed in the source. Without reported harm or a clear hazard, this is classified as a precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). A total of 66 units of the affected procedure packs were distributed nationwide in the United States.

The procedure packs are being recalled in association with a voluntary recall of the syringes by their manufacturer, Sol-Millennium Medical, Inc. The specific reason for the manufacturer's recall of the syringes is not provided in this notice.

The recalled product can be identified by Part Number 58001503, UDI-DI 30886158024348, and Lot Number 6069199.

Customers should discontinue use of the affected procedure packs and contact Beaver Visitec International regarding return or disposal of the product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;
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 (3)

  • Part Number: 58001503
  • UDI-DI: 30886158024348
  • Lot/Batch Number: 6069199

Distribution

Distributed nationwide across the United States.