The Recall Desk
ModerateFDA (Devices)·Z-2857-2024·Announced 2024-09-04

Sol-M Syringes in BVI CustomEyes Procedure Packs Recalled Voluntarily

BVI is recalling CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to Sol-M's voluntary recall of those syringes.

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 Class II medical device recall with no reported illnesses, injuries, or specified hazard in the source notice. Per the severity rubric, voluntary precautionary recalls without reported harm are classified as Moderate.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical (Sol-M) due to a voluntary recall of those syringes by Sol-M.

The recalled items are CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001314, UDI-DI: 30886158023440, Lot Number 6049642). These packs were distributed nationwide in the United States.

The FDA notice does not specify the reason for Sol-M's voluntary recall. Healthcare providers holding these products should contact their supplier for further instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001314;
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: 58001314
  • UDI-DI: 30886158023440
  • Lot/Batch Number: 6049642

Distribution

Distributed nationwide across the United States.