Events

Recall of HEARTSINE SAMARITAN PAD SAM 350P

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HEARTSINE TECHNOLOGIES LTD..

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
    55303
  • Event Risk Class
    III
  • Event Initiated Date
    2014-06-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    An issue was detected with the seal on the foil pouch which contains the electrodes within the pad-pak/pedi-pak. on a samll number the final seal of the defibrillation electrode pouch was difficult to open. after an investigation it was found that the supplier of the electrodes to heartsine technologies ltd. made a change to the manufacturing process which meant an excessive amount of hot melt glue was applied to the final seal of the pouches.

Device

HEARTSINE SAMARITAN PAD SAM 350P
  • Model / Serial
    Model Catalog: SAM 350P (Lot serial: >10 numbers contact mfg)
  • Product Description
    Heartsine Samaritan PAD SAM 350P
  • Manufacturer
    HEARTSINE TECHNOLOGIES LTD.

Manufacturer

HEARTSINE TECHNOLOGIES LTD.
  • Manufacturer Address
    BELFAST
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC