Events

Recall of Device Recall MATResponder Tourniquet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pyng Medical Corporation.

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
    72096
  • Event Risk Class
    Class 2
  • Event Number
    Z-0228-2016
  • Event Initiated Date
    2015-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139859
  • 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
    Tourniquet, nonpneumatic - Product Code GAX
  • Reason
    Once tested, it is required that the tourniquet be returned to its ready position then placed in its packaging. each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its ready position prior to packaging.
  • Action
    PYNG Medical sent Recall Notification letters dated August 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Please immediately cease use of the MATResponder and MATCombat tourniquet lots specified above. Inform all of your teams to cease use of or distribution of these lots. Please immediately place all MATResponder Tourniquets and MATCombat Tourniquets that you have in inventory into a quarantined location. For further questions please call (604) 303-7964. .

Device

Device Recall MATResponder Tourniquet
  • Model / Serial
    MATR: lot numbers; SL115802 (Exp 07/2024), SL12136 (Exp 08/2024), SL121360 (Exp 12/2024), SL114711 (Exp 01/2024) MATC - lot numbers : SL12131 (Exp 07/2024), SL121312 (Exp 08/2024), SL113171 (Exp 10/2023).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Colombia, France, Canada, Italy, Germany, Finland, United Kingdom, Australia, The Netherlands, Japan, Hungary, Indonesia, Israel, Mexico, Poland and Spain.
  • Product Description
    MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; || MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; || MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes || manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs
  • Manufacturer
    Pyng Medical Corporation

Manufacturer

Pyng Medical Corporation
  • Manufacturer Address
    Pyng Medical Corporation, 210-13480 Crestwood Pl, Richmond Canada
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA