Events

Recall of SAM JUNCTIONAL TOURNIQUET 2 TARGET COMPRESSION DEVICES (1 WITH EXTENDER) HAND PUMP AUXILIARY STRAP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FERNO CANADA 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
    129491
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-18
  • 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
    Sam medical is voluntarily recalling the sam junctional tourniquet (sjt) auxiliary (accessory) strap which is intended for use in the control of difficult bleeds in the axilla area. only the auxiliary strap is affected. the remaining components of the sjt are not impacted by this recall and function as intended. it was determined through customer feedback and subsequent internal testing that the rear retaining clip failed in a very small number of devices during training demonstrations. no report of patient injury nor has the device been reported to fail during actual patient use.

Device

SAM JUNCTIONAL TOURNIQUET 2 TARGET COMPRESSION DEVICES (1 WITH EXTENDER) HAND PUMP AUXILIARY STRAP
  • Model / Serial
    Model Catalog: SJT 102 (Lot serial: 5/15/13)
  • Product Description
    AM JUNCTIONAL TOURNIQUET 2 TARGET COMPRESSION DEVICES (1 WITH EXTENDER) HAND PUMP AUXILIARY STRAP
  • Manufacturer
    FERNO CANADA INC.

Manufacturer

FERNO CANADA INC.