Events

Retiro De Equipo (Recall) de Device Recall ENDOPATH Probe Plus II

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
    50510
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0661-2009
  • Fecha de inicio del evento
    2008-12-09
  • Fecha de publicación del evento
    2009-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75710
  • 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
    Electrosurgery Probe - Product Code GCJ
  • Causa
    Nickel exposure: the stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. ethicon endo-surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens.
  • Acción
    On 12/9/2008 Ethicon Endo-Surgery sent recall notification letters to their customers instructing them to stop using the product, examine all inventory to determine if they have the affected product on hand and remove the affected products from inventory. They requested that each customer complete the Business Reply Form and fax it back to Stericycle and also return any affected product to Stericycle.

Device

Device Recall ENDOPATH Probe Plus II
  • Modelo / Serial
    Product Code EPS07 - Lot # E4KC1V, Exp Date 2013-01; Lot # E4KJ1J, Exp Date 2013-02; Lot # E4KM09, Exp Date 2013-02; Lot # E4KV1N, Exp Date 2013-03; Lot # E4KZ5M, Exp Date 2013-03; Lot # E4L464, Exp Date 2013-04; Lot # E4L664, Exp Date 2013-04; Lot # E4LA0W, Exp Date 2013-05; Lot # E4LC3M, Exp Date 2013-05; Lot # E4LE63, Exp Date 2013-05; Lot # E4LJ89, Exp Date 2013-06; Lot # E4LK9K, Exp Date 2013-06; Lot # E4LR3Y, Exp Date 2013-07; Lot # E4LX68, Exp Date 2013-07; Lot # E4LX88, Exp Date 2013-07; Lot # E4M071, Exp Date 2013-08; Lot # E4M43P, Exp Date 2013-08; Lot # E4M83K, Exp Date 2013-09; and Lot # E4M98Y, Exp Date 2013-09.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, PUERTO RICO, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, DOMINICAN REPUBLIC, EGYPT, ENGLAND, EQUADOR, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, PAKISTAN, PANAMA, POLAND, REPUBLIC OF YEMEN, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, URUGUAY, and VENEZUELA.
  • Descripción del producto
    Ethicon Endo-Surgery ENDOPATH¿ Electrosurgery Probe Plus II 29 cm Right Angle Probe (Product Code EPS07)
  • 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