Events

Recall of RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fisher & Paykel Healthcare 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
    31046
  • Event Risk Class
    Class 2
  • Event Number
    Z-0553-05
  • Event Initiated Date
    2004-12-21
  • Event Date Posted
    2005-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37061
  • 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
    Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
  • Reason
    Pressure elbow may be partly occluded.
  • Action
    Recall was initiated on 12/17/2004 at all firm locations and distributors worldwide. The recall letter includes instructions for performing a mitigation until new stock is supplied.

Device

RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory ...
  • Model / Serial
    Lot umbers in the range 040701 to 041216
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.
  • Manufacturer
    Fisher & Paykel Healthcare Inc

Manufacturer

Fisher & Paykel Healthcare Inc
  • Manufacturer Address
    Fisher & Paykel Healthcare Inc, 22982 Alcalde Drive 101, Laguna Hills CA 92653
  • Source
    USFDA