Events

Retiro De Equipo (Recall) de Device Recall MATResponder Tourniquet

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Pyng Medical Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    72096
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0228-2016
  • Fecha de inicio del evento
    2015-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139859
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Tourniquet, nonpneumatic - Product Code GAX
  • Causa
    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.
  • Acción
    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
  • Modelo / 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).
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    Pyng Medical Corporation, 210-13480 Crestwood Pl, Richmond Canada
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA