Events

Retiro De Equipo (Recall) de ENDOPATHETS Endoscopic Linear Cutter

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 Ethicon Endo-Surgery 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
    48604
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2162-2008
  • Fecha de inicio del evento
    2008-04-24
  • Fecha de publicación del evento
    2008-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71718
  • 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
    Surgical Cutter - Product Code FZT
  • Causa
    The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
  • Acción
    Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.

Device

ENDOPATHETS Endoscopic Linear Cutter
  • Modelo / Serial
    Batch #s: D4G80V, D4G97P, D4G97R, D4GA09, D4GC96, D4GC97, D4GF6G, D4GH13, D4GH5J, D4GJ58, D4GK8C, D4GL2R, D4GN4E, D4GN99, D4GR13, D4GT54, D4GT6V, D4GT93, D4GT9Z, D4GV02, D4GV03, D4H03D, D4H03F, D4H042, D4H052, D4H053, D4H090, D4H091, D4H092, D4H441, D4H442, D4H50M, D4H58Z, D4H68R, D4H68T, D4H69Z, D4H99F, D4H99G, D4HC0R, D4HC1C, D4HE3E, D4HF3M, D4HG1D, D4HG1E, D4HH26, D4HJ3W, D4HJ3X, D4HK4P, D4HL73, D4HM13, D4HM15, D4HP2L, D4HP2M, D4HP6G, D4HP6J, D4HR98, D4HR9A, D4HV3A, D4HW7Y, D4HX1D, D4HY6J, D4HY98, D4HZ1M, D4HZ1N, D4J09J, D4J17L
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.
  • Descripción del producto
    ENDOPATH¿ETS Endoscopic Linear Cutter, TSW35. || Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Dirección del fabricante
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA