Events

Recall of LIFEPAK(R) defibrillation electrodes

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
    78303
  • Event Risk Class
    Class 1
  • Event Number
    Z-0186-2018
  • Event Initiated Date
    2017-10-27
  • 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=159096
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    The infant artwork on the product instructs incorrect pad placement. also, the artwork is missing the type bf patient connection and high voltage warning symbols.
  • Action
    The firm Physio Control, initiated their field action on 10/27/2017 by issuing a press release. The firm followed this with a recall notice dated 10/23/2017, to the direct consignees on 11/03/2017. The letter described the product, explained the problem and provided the following instructions: Quarantine the affected lots;contact Physio-Control at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday  Friday to arrange for replacement of your unused electrodes and "Upon receipt of this notification, post a copy of the enclosed Correct Electrode and Packaging Labeling with each of your AEDs, which shows the correct placement of the electrodes." Physio_Control will provide replacement products for all unused affected Electrodes. Should you have any questions about this Product Recall, please contact us at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday  Friday.

Device

LIFEPAK(R) defibrillation electrodes
  • Model / Serial
    713609, 717912, 713904, 718033, 715008, 719323
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand.
  • Product Description
    LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 || The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
  • 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