The Recall Desk
ModerateFDA (Devices)·Z-2823-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with defective Sol-M syringes recalled

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. These packs 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 recall with no reported illnesses, injuries, or hospitalizations. The voluntary nature of the recall and lack of reported harm align with the rubric's definition of voluntary precautionary recalls as Moderate (2).

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58000775) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The affected lot is Batch Number 6070132 (UDI-DI: 30886158020319), with 40 units distributed.

These procedure packs were distributed nationwide throughout the United States. The syringes present in the packs are the subject of the voluntary recall initiated by Sol-M.

Patients and healthcare providers in possession of these procedure packs should contact Beaver Visitec International for information regarding the recall and any remedial actions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775;
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: 58000775
  • UDI-DI: 30886158020319
  • Lot/Batch Number: 6070132

Distribution

Distributed nationwide across the United States.