Events

Recall of Device Recall Transonic ADT 1018 Flow QC Clear Advantage Tubing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Transonic Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79750
  • Event Risk Class
    Class 2
  • Event Number
    Z-1776-2018
  • Event Initiated Date
    2018-02-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163235
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Hemodialysis Catheter Luer End Cap - Product Code PEH
  • Reason
    The sterility of the device cannot be assured. there is a potential for an increased risk of infection.
  • Action
    The recalling firm has sent all of its customers a Recall Notification Letter dated February 15, 2018, and has included a Customer Reponse Form that requests that customers either return or destroy the ADT1018 Tubing in their possession. For further questions, please call (800) 353-3569.

Device

Device Recall Transonic ADT 1018 Flow QC Clear Advantage Tubing
  • Model / Serial
    Lots B151130E2 and B161115E0
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.
  • Product 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.
  • Manufacturer
    Transonic Systems Inc

Manufacturer

Transonic Systems Inc
  • Manufacturer Address
    Transonic Systems Inc, 34 Dutch Mill Rd, Ithaca NY 14850-9785
  • Manufacturer Parent Company (2017)
    Measurement Innovations Corp
  • Source
    USFDA