Events

Retiro De Equipo (Recall) de Pressure Tourniquet Cuffs

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 Stryker Sustainability Solutions.

¿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
    75221
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0324-2017
  • Fecha de inicio del evento
    2016-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149691
  • 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, pneumatic - Product Code KCY
  • Causa
    Issue with the process for detection of leaking pressure tourniquet cuffs (ptc). leaking ptc devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during bier block requiring medical intervention.
  • Acción
    Stryker Sustainability Solutions sent an Customer Notification letter September 19, 2016. Customers were instructed to discontinue use of the affected products. The letter stated to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices containing expiration dates from May 2016-May 2018 remain in inventory. This form must be completed even if no affected product is found. Use the following reference number as you complete the form: [Ship to Account #] If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit for all affected devices returned will be issued to the facility. .Adverse reactions or quality problems experienced with the use of this product may be reported to: o Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 o http://www.stryker.com/productexperience/ o The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Device

Pressure Tourniquet Cuffs
  • Modelo / Serial
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. distribution nationwide. No foreign distribution
  • Descripción del producto
    Reprocessed Pressure Tourniquet Cuff (PTC) || Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Dirección del fabricante
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA