The Recall Desk
ModerateFDA (Devices)·Z-2791-2024·Announced 2024-09-04

FDA Recalls BVI CustomEyes Procedure Packs with Sol-M Syringes

The FDA is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes under a voluntary recall from the syringe manufacturer affecting nationwide distribution.

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 FDA Class II recall involves a voluntary recall with no reported illnesses or injuries, indicating a precautionary measure per the Moderate severity criterion.

Plain-English summary

Beaver Visitec International, Inc. (BVI) is recalling CustomEyes Procedure Packs that contain Sol-Millennium Medical (Sol-M) Luer Lock and Luer Slip 1ml syringes (Part Number 584742). A total of 122 units were distributed nationwide.

The recall is being conducted voluntarily. The affected syringes are the subject of a separate recall by their manufacturer, Sol-M. The FDA has classified this recall as Class II.

This recall affects healthcare facilities and providers who received BVI CustomEyes Procedure Packs. The affected packs can be identified by Part Number 584742, UDI-DI 30886158008188, and Lot Number 6072504.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584742;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • syringe-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: 584742
  • UDI-DI:30886158008188
  • Lot/Batch Number: 6072504

Distribution

Distributed nationwide across the United States.