Events

Retiro De Equipo (Recall) de Device Recall MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz

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 Merz Aesthetics, Inc..

¿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
    60851
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0694-2012
  • Fecha de inicio del evento
    2011-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106644
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Causa
    Merz aesthetics is initiating a medical device recall on tsk closed tip cannula (27ga x 25mm) due to a labeling error on the secondary (outer) packaging. the outer package label states that the carton contains cannulas that are 27ga x 25 mm in size instead of 27g x 38 mm. length of the cannula is a matter of user preference and is unlikely to impact patient safety.
  • Acción
    Merz Aesthetics Inc, initially contacted customers by telephone on December 16, 2011. They were informed that the wrong size cannula were sent with their last order and would need to be returned and a replacement order would be sent. . Merz Aesthetics sent a "Urgent Medical Device Recall" letter dated January 6, 2012. The letter identified the product the problem and the action needed to be taken by the customer. In addition, if you have further distributed this product, please identify your customers and notify them of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You may contact Merz Aesthetics Customer Service at (866) 862-1211 or (262) 835- 3333 ,for instructions regarding the return and immediate replacement of the product, or if you have any further questions or concerns..

Device

Device Recall MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, D...
  • Modelo / Serial
    Lot #1029402
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of CA, NY, OK, and TN.
  • Descripción del producto
    MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. || The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.
  • Manufacturer
    Merz Aesthetics, Inc.

Manufacturer

Merz Aesthetics, Inc.
  • Dirección del fabricante
    Merz Aesthetics, Inc., 4133 Courtney Rd Ste 10, Franksville WI 53126-9127
  • Empresa matriz del fabricante (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    USFDA