Events

Recall of Device Recall 9051 Electrode Adapter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Science Corporation.

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
    47205
  • Event Risk Class
    Class 3
  • Event Number
    Z-1616-2008
  • Event Initiated Date
    2008-01-23
  • Event Date Posted
    2008-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69031
  • 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 defibrillator - Product Code MKJ
  • Reason
    Adaptor cable incorrectly manufactured: the red and white connector ends of the adapter are switched. therefore, the cable will not connect to the electrodes as indicated in the instructions.
  • Action
    Consignees were notified by an Urgent Medical Device Recall letter sent on 01/23/2008. The letter instructs users to check each cable of the affected lot to ensure that it properly connects to the electrode. Users were also instructed to return any defective product to the recalling firm for a replacement. For additional information, contact 1-888-466-8686 x2041.

Device

Device Recall 9051 Electrode Adapter
  • Model / Serial
    Lot Numbers: W029275 and W029476.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.
  • Product Description
    9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Manufacturer Address
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Manufacturer Parent Company (2017)
    Cardiac Science Corporation
  • Source
    USFDA