Events

Recall of Device Recall PadPak and PediPak accessories for the HeartSine SamaritanPAD 300P and 350P device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heartsine Technologies, Limited.

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
    68703
  • Event Risk Class
    Class 2
  • Event Number
    Z-2115-2014
  • Event Initiated Date
    2014-06-12
  • Event Date Posted
    2014-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128482
  • 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
    A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
  • Action
    HeartSine notified distributors in the United States by e-mail on June 12, 2014 and by follow-up letter on June 13, 2014. Distributors were given a letter to use in communications with customers on June 17, 2014. Customers were instructed to return affected product to there distributors. Distributors were asked to return the affected product to HeartSine. In order to effect an immediate return, replacement Pad-Paks and Pedi-Paks have already been delivered to all respective distributors. A seconde letter, dated June 30th, was sent to end users to clarify where on the label to find lot specific information. For question contact Quality Manager at +44 (0)28 90 93 94 19.

Device

Device Recall PadPak and PediPak accessories for the HeartSine SamaritanPAD 300P and 350P device
  • Model / Serial
    Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
  • Product Description
    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). || Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
  • Manufacturer
    Heartsine Technologies, Limited

Manufacturer

Heartsine Technologies, Limited
  • Manufacturer Address
    Heartsine Technologies, Limited, 203 Airport Road West, Belfast United Kingdom
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA