Events

Retiro De Equipo (Recall) de Device Recall FemFlex II Pediatric Femoral Arterial Cannula

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 Edwards Lifesciences, LLC.

¿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
    70820
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1371-2015
  • Fecha de inicio del evento
    2015-03-23
  • Fecha de publicación del evento
    2015-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134907
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    Edwards lifesciences is recalling fem-flex ii pediatric femoral arterial cannula sizes 8, 10, 12 french because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.
  • Acción
    The firm, Edwards, sent an "URGENT - PRODUCT RECALL - ACTION REQUIRED" letter dated March 23, 2015 via FED EX on March 27, 2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to review entire inventory for the lots listed; complete and return attached acknowledgment form via fax to Edwards Customer Service at 800.422.9329. within three days of receipt of this Field Safety Notice; contact Customer Service at 800.422.3278 to obtain an RGA number and replacement product; return affected product to Edwards Lifesciences, Attn: Cirilo Chaparro, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA#XXX; and transfer this notice to other organizations if the affected devices have been transferred to any another facilities. If you have any questions that have not been answered by this letter, please call Edwards Customer Services at 800.424.3278 from the hours of 6:00AM - 4:30PM PST; Edwards Customer Service at (800) 268-3993 from 8:00AM  4:30PM Eastern Time or contact your Edwards sales representative concerning the recall.

Device

Device Recall FemFlex II Pediatric Femoral Arterial Cannula
  • Modelo / Serial
    Model/Lot Numbers: FEMII008A/59751073, 59775775, 59775776, 59775777 & 59852930; FEMII008AT/59807985, 59867050, & 59873263;  FEMII008V/59873250 & 59873251; FEMII010A/59740468, 59773806, 59792415, 59792416 & 59852934;  FEMII010AT/ 59747819, 59807986,59852935, 59890916 & 59896910; FEMII010V/59751074, 59849119 & 59890924; FEMII012A/ 59801792,59867064, 59884766 & 59884778  FEMII012AT/59852940 & 59867051; and  FEMII012V/59723307, 59796683, 59849124 & 59873252
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. || Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Dirección del fabricante
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA