Events

Recall of Device Recall Internal Sterilizable Paddles and Handles without discharge control

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Physio Control, 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
    51173
  • Event Risk Class
    Class 2
  • Event Number
    Z-1171-2009
  • Event Initiated Date
    2009-02-16
  • Event Date Posted
    2009-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78905
  • 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
    Low-Energy Dc-Defibrillator (including paddles) - Product Code LDD
  • Reason
    Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
  • Action
    Recalling firm sent Urgent Medical Device Recall letters, dated 2/2009, advising customers to discontinue use of the listed sterilization methods and to remove them from service since there is no sterilization method that can be supported by current data. They are to use the enclosed form to identify and confirm if they have the listed products and follow the instructions on the form for returning information to the firm.

Device

Device Recall Internal Sterilizable Paddles and Handles without discharge control
  • Model / Serial
    Internal Defibrillation Handles without discharge control:  Part Numbers 800441-03 thru 800441-06  Internal Defibrillation Electrodes (threaded end):  Part Numbers: 802154-10 thru 802154-19  Sterilization labeling affects ALL part numbers referenced above.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Manufacturer Address
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA