🔍 RecallPedia

MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

Class I - Dangerous
🏥 Medical Devices Recalled: February 10, 2023 Unetixs Vascular Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    All Serial Numbers
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Unetixs Vascular, Inc.
Reason for Recall:
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

Product Codes/Lot Numbers:

All Serial Numbers

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1195-2023

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