Events

Retiro De Equipo (Recall) de Device Recall Transseptal Sheath Introducer Kits

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 Thomas Medical Products 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
    54525
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0815-2010
  • Fecha de inicio del evento
    2010-02-01
  • Fecha de publicación del evento
    2010-03-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88641
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    Radiopaque tip may fracture.
  • Acción
    Thomas Medical Products, A GE Healthcare Company, issued an "Urgent Medical Device Correction" letter dated February 1, 2010. Consignees were informed of the affected product then asked to cease distribution, return any product to firm and contact all sub-accounts. For further information, contact Thomas Medical Products Customer Service at 1-866-446-3003.

Device

Device Recall Transseptal Sheath Introducer Kits
  • Modelo / Serial
    Catalog Numbers: XD252500, XD252501, XD252502, XD252503, XD252504, XD252505, XD252506, XD252507, XD252508, XD252509, TF8-38-62-5, TF8-38-62-B1, FCL-127-00, FCL-127-01, FCL-127-02, FCL-127-03, FCL-127-04, FCL-127-05, FCL-127-06, FCL-127-07, FCL-127-08 and FCL-127-09; and  Lot Numbers: 25346, S20361, S20361X1, S20362, S20362X1, S20452, S20501, S20501X1, S20502, S20502X1, S20503, S20504, S20971, S20980, S21218, S21218X1, S21244, S21270, S21270X1, S21271, S21272, S21273, S21278, S21571, S21828, S21903, S21904, S21905, S21906, S21940, S21973, S22005, S22019, S22020, S22057, S22088, S22094, S22095, S22096, S22107, S22108, S22235, S22236, S22237, S22237X1, S22238, S22239, S22240, S22241, S22242, S22243, S22246, S22495, S22496, S22497, S22498, S22598, S22613, S22614, S22670, S22677, S22739, S22739X1, S22754, S22871, S22880, S22890, S22908, S22939, S22950, S23012, S23163, S23380, S23400, S23401, S23449, S23454, S24213, S24759, S25171, S25393, S25536, S25618 S25647, S26047, S26129, S26480, S26969, S26970, S27089, S27367, S27368, S27369, S27466, S27587, S27631, S27632, S27647, S27767, S27768, S27772, S27953, S27966, S28055, S28539, S28555, S28587, S28796, S29034, S29035, S29527, S29659, S29660, S29934, S30137, S30427, S30428 and S30519.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (CA, MA and NJ), Canada, Germany, and the United Kingdom.
  • Descripción del producto
    Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton. || Intended to allow left heart catheterization procedure to occur through the right atrium.
  • Manufacturer
    Thomas Medical Products Inc

Manufacturer

Thomas Medical Products Inc
  • Dirección del fabricante
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA