Events

Recall of Device Recall Zoll Medical Corp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Detek, 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
    69145
  • Event Risk Class
    Class 2
  • Event Number
    Z-2658-2014
  • Event Initiated Date
    2014-08-26
  • Event Date Posted
    2014-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129741
  • 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
    Sterility of device is not assured.
  • Action
    BioDetek sent an Urgent Device Correction letter dated August 26, 2014, to all affected customers via UPS overnight delivery. There has also been notifications addressed to the 4 International accounts on August 27, 2014. Customers were requested to return the suspect product(s) in their possession and complete the Device Correction Response Return Form provided to each customer. Customer inventory will be replaced as soon as replacement electrodes are processed. Customers with questions can contact the technical support numbers at 1 (800) 348-9011 or +1 (978) 421-9460 24/7. For questions regarding this recall call 401-729-1400.

Device

Device Recall Zoll Medical Corp
  • Model / Serial
    Lot Number: 2314
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
  • Product Description
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with || 10-ft (3 m) leadwires || Part number: 8900-4052 || These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
  • Manufacturer
    Bio-Detek, Inc.

Manufacturer

Bio-Detek, Inc.
  • Manufacturer Address
    Bio-Detek, Inc., 525 Narragansett Park Dr, Pawtucket RI 02861-4323
  • Source
    USFDA