The Recall Desk
ModerateFDA (Devices)·Z-2889-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs recalled for Sol-M syringe defects

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall initiated by the syringe manufacturer. No illnesses or injuries have been reported.

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 recall with no reported illnesses or injuries. The actual hazard associated with the Sol-M syringes is not detailed in the recall notice, making it a precautionary measure. Per the rubric, voluntary recalls with no reported harm typically score as Moderate.

Plain-English summary

BVI CustomEyes Procedure Packs containing 1ml Sol-M Luer Lock and Luer Slip syringes are being recalled. The affected packs (Part Number 58001608, Lot 6067129) have been distributed nationwide in the United States. The 48 units affected include procedure packs that contain syringes manufactured by Sol-Millennium Medical, Inc.

The recall is voluntary and was initiated due to concerns with the Sol-M syringes themselves. The low dead space and luer slip tip syringe design in these packs is the subject of the manufacturer's recall notice. No illnesses or injuries have been reported in connection with this recall as of the notice date.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001608;
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: 58001608
  • UDI-DI: 30886158031537
  • Lot/Batch Number: 6067129

Distribution

Distributed nationwide across the United States.