Events

Rappel de Device Recall MATResponder Tourniquet

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Pyng Medical Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72096
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0228-2016
  • Date de mise en oeuvre de l'événement
    2015-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139859
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Tourniquet, nonpneumatic - Product Code GAX
  • Cause
    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
  • Modèle / numéro de série
    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).
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Pyng Medical Corporation, 210-13480 Crestwood Pl, Richmond Canada
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA