🔍 RecallPedia

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

Class I - Dangerous
🏥 Medical Devices Recalled: February 15, 2018 Transonic Systems Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots B151130E2 and B161115E0
  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:
Transonic Systems Inc
Reason for Recall:
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

Product Codes/Lot Numbers:

Lots B151130E2 and B161115E0

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1776-2018

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