Events

Recall of Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111

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
    34248
  • Event Risk Class
    Class 2
  • Event Number
    Z-0695-06
  • Event Initiated Date
    2005-12-20
  • Event Date Posted
    2006-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43334
  • 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
    Risk of fire. the manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. this may lead to a potential risk of fire.
  • Action
    On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.

Device

Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111
  • Model / Serial
    Affected lots for all catalogue numbers: 041101-050331(inclusive).
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
  • Product Description
    Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111
  • 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