Events

Recall of Cardio Medical Products Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardio Medical Products.

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
    65462
  • Event Risk Class
    Class 2
  • Event Number
    Z-1669-2013
  • Event Initiated Date
    2013-04-26
  • Event Date Posted
    2013-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118978
  • 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
    Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
  • Reason
    Covidien received customer reports of arcing/sparking on the defibrillation electrode leadwire which may affect cardio medical products inc. defibrillator electrodes model number o101.
  • Action
    Cardio Medical Products, Inc. issued an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and segregate any product with the affected lot numbers and return affected product according to the instructions for product credit by contacting the Customer Service group at 1-800-962-9888, option 1, then option 2, and reference the recall letter to request a Return Goods Authorizing (RGA). Customers were instructed to complete the enclosed Verification Form and return it to Covidien by fax to 800-895-6140, even if they did not have any of the affected lots. Customers were also instructed to report any issues to the Quality Assurance Group to ensure proper device reporting procedures are followed. Customers with questions were instructed to call 1-800-962-9888, option 8, then ext 2500. For questions regarding this recall call 973-586-9500.

Device

Cardio Medical Products Inc.
  • Model / Serial
    510 K K103159  Part number O101  Lot numbers Y111412-2 Y111912-17 Y020613-03
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only || Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 || www.cardiomedicalproducts.com || (800) 227-3633 (973) 586-9624 FAX || Defibrillator
  • Manufacturer
    Cardio Medical Products

Manufacturer

Cardio Medical Products
  • Manufacturer Address
    Cardio Medical Products, 385 Franklin Ave, Rockaway NJ 07866-4037
  • Manufacturer Parent Company (2017)
    Cardio Medical Products
  • Source
    USFDA