Events

Retiro De Equipo (Recall) de Device Recall Centurion C.A.P.D. Tubing Exchange Tray

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 Centurion Medical Products.

¿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
    55885
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1937-2010
  • Fecha de inicio del evento
    2010-03-16
  • Fecha de publicación del evento
    2010-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92156
  • 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
    Start/Stop Dialysis Tray - Product Code FKG
  • Causa
    The 3m micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.
  • Acción
    The firm sent Urgent Recall Product Notices to its two customers dated 3/16/2010. The letter explained that the tape may not adhere properly. The consignees were instructed to remove any kits containing the recalled tape from their inventory, if the tape was used to secure dialysis needles or pressure dressings. If the tape was used for other purposes, the kits could still be used. The recall letter included a reply form for customers to complete and email or fax back. Upon receipt of the form, a Centurion Representative will contact them to retrieve affected product. Customers should contact Matthew Price at 517-546-5400 ext. 1135, if further info is needed.

Device

Device Recall Centurion C.A.P.D. Tubing Exchange Tray
  • Modelo / Serial
    801218, 802188, 2009080380 and 2009081080.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AR and OH.
  • Descripción del producto
    C.A.P.D. Tubing Exchange Tray, HT80, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI.
  • Manufacturer
    Centurion Medical Products

Manufacturer

Centurion Medical Products
  • Dirección del fabricante
    Centurion Medical Products, 301 Catrell Dr, Howell MI 48843-1703
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA