Events

Recall of Device Recall Medstorm Adult Radiolucent Electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heart Sync, 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
    57736
  • Event Risk Class
    Class 2
  • Event Number
    Z-1372-2011
  • Event Initiated Date
    2010-12-17
  • Event Date Posted
    2011-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97447
  • 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
    Electrode, electrocardiograph, multi-function - Product Code MLN
  • Reason
    The seal on the electrode pouch may be open, exposing the electrode to the outside environment. the package does have a caution statement that states, " do not open package until immediately prior to using electrodes. and electrodes may dry out when removed from packaging and exposed to air.
  • Action
    Heart Sync, Inc sent an URGENT MEDICAL DEVICE RECALL letter dated December 23, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Examine their inventory and quarantine product that was subject to the recall that was not sealed properly. Contact any customers if they further distributed the product and notify them at once of this product recall. Contact the firm if they had any unused product. The firm would issue a UPS Call Tag to have the product returned to them and the firm would send replacement product as soon as they were notified. Complete and return the Recall Return Response Form to the firm in the attached prepaid envelope. For any questions regarding this recall call 734-213-5530.

Device

Device Recall Medstorm Adult Radiolucent Electrode
  • Model / Serial
    Lot # Y032709-1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada
  • Product Description
    Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. || The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
  • Manufacturer
    Heart Sync, Inc

Manufacturer

Heart Sync, Inc
  • Manufacturer Address
    Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • Manufacturer Parent Company (2017)
    Heart Sync, Inc
  • Source
    USFDA