• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 31
  • Fabricante 6
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Vaxcel PICC with PASV Valve Technology
  • Tipo de evento
    Recall
  • ID del evento
    30572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0404-05
  • Fecha de inicio del evento
    2004-11-22
  • Fecha de publicación del evento
    2005-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36141
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Causa
    Catheter separation immediately distal to the nose of the suture wing.
  • Acción
    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Retiro De Equipo (Recall) de Device Recall Vaxcel PICC with PASV Valve Technology
  • Tipo de evento
    Recall
  • ID del evento
    30572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0405-05
  • Fecha de inicio del evento
    2004-11-22
  • Fecha de publicación del evento
    2005-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36142
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Causa
    Catheter separation immediately distal to the nose of the suture wing.
  • Acción
    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Retiro De Equipo (Recall) de Device Recall Vaxcel PICC with PASV Valve Technology
  • Tipo de evento
    Recall
  • ID del evento
    30572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0406-05
  • Fecha de inicio del evento
    2004-11-22
  • Fecha de publicación del evento
    2005-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36145
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Causa
    Catheter separation immediately distal to the nose of the suture wing.
  • Acción
    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Retiro De Equipo (Recall) de Device Recall Vaxcel PICC with PASV Valve Technology
  • Tipo de evento
    Recall
  • ID del evento
    30572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0407-05
  • Fecha de inicio del evento
    2004-11-22
  • Fecha de publicación del evento
    2005-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36154
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Causa
    Catheter separation immediately distal to the nose of the suture wing.
  • Acción
    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Retiro De Equipo (Recall) de Device Recall BioMed Devices
  • Tipo de evento
    Recall
  • ID del evento
    30580
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0423-05
  • Fecha de inicio del evento
    2004-12-06
  • Fecha de publicación del evento
    2005-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36156
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Adapters may be occluded potentially preventing inhalation.
  • Acción
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Retiro De Equipo (Recall) de Device Recall BioMed Devices
  • Tipo de evento
    Recall
  • ID del evento
    30580
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0424-05
  • Fecha de inicio del evento
    2004-12-06
  • Fecha de publicación del evento
    2005-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36164
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Adapters may be occluded potentially preventing inhalation.
  • Acción
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Retiro De Equipo (Recall) de Device Recall BioMed Devices
  • Tipo de evento
    Recall
  • ID del evento
    30580
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0425-05
  • Fecha de inicio del evento
    2004-12-06
  • Fecha de publicación del evento
    2005-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36165
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Adapters may be occluded potentially preventing inhalation.
  • Acción
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Retiro De Equipo (Recall) de Device Recall BioMed Devices
  • Tipo de evento
    Recall
  • ID del evento
    30580
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0426-05
  • Fecha de inicio del evento
    2004-12-06
  • Fecha de publicación del evento
    2005-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36166
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Adapters may be occluded potentially preventing inhalation.
  • Acción
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Retiro De Equipo (Recall) de Device Recall BioMed Devices
  • Tipo de evento
    Recall
  • ID del evento
    30580
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0427-05
  • Fecha de inicio del evento
    2004-12-06
  • Fecha de publicación del evento
    2005-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36167
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Adapters may be occluded potentially preventing inhalation.
  • Acción
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Retiro De Equipo (Recall) de ACT diff 2 Analyzer || (Automated differential cell counter)
  • Tipo de evento
    Recall
  • ID del evento
    30587
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0339-05
  • Fecha de inicio del evento
    2004-12-03
  • Fecha de publicación del evento
    2004-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36170
  • 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
    Counter, Differential Cell - Product Code GKZ
  • Causa
    Erroneous results issue when monoject blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. results are lower than if cap had not been removed.
  • Acción
    A letter issued to users informing them of the incompatability of the Coulter ACT diff 2 Analyzer with the use of Monoject blood collection tubes made by Tyco Healthcare Group/Kendall Healthcare. Customers choosing to use these tubes are instructed to uncap the tubes and analyze the samples,as open vial samples.
Retiro De Equipo (Recall) de Device Recall BioMed Devices
  • Tipo de evento
    Recall
  • ID del evento
    30580
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0428-05
  • Fecha de inicio del evento
    2004-12-06
  • Fecha de publicación del evento
    2005-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36173
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Adapters may be occluded potentially preventing inhalation.
  • Acción
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Retiro De Equipo (Recall) de Device Recall BioMed Devices
  • Tipo de evento
    Recall
  • ID del evento
    30580
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0429-05
  • Fecha de inicio del evento
    2004-12-06
  • Fecha de publicación del evento
    2005-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36174
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Adapters may be occluded potentially preventing inhalation.
  • Acción
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Retiro De Equipo (Recall) de Device Recall BioMed Devices
  • Tipo de evento
    Recall
  • ID del evento
    30580
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0430-05
  • Fecha de inicio del evento
    2004-12-06
  • Fecha de publicación del evento
    2005-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36175
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Adapters may be occluded potentially preventing inhalation.
  • Acción
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
Retiro De Equipo (Recall) de Device Recall Vaxcel PICC with PASV Valve Technology
  • Tipo de evento
    Recall
  • ID del evento
    30572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0408-05
  • Fecha de inicio del evento
    2004-11-22
  • Fecha de publicación del evento
    2005-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36179
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Causa
    Catheter separation immediately distal to the nose of the suture wing.
  • Acción
    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Retiro De Equipo (Recall) de Device Recall Vaxcel PICC with PASV Valve Technology
  • Tipo de evento
    Recall
  • ID del evento
    30572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0409-05
  • Fecha de inicio del evento
    2004-11-22
  • Fecha de publicación del evento
    2005-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36180
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Causa
    Catheter separation immediately distal to the nose of the suture wing.
  • Acción
    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Retiro De Equipo (Recall) de Device Recall Vaxcel PICC with PASV Valve Technology
  • Tipo de evento
    Recall
  • ID del evento
    30572
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0410-05
  • Fecha de inicio del evento
    2004-11-22
  • Fecha de publicación del evento
    2005-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36183
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Causa
    Catheter separation immediately distal to the nose of the suture wing.
  • Acción
    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Retiro De Equipo (Recall) de Device Recall Primary Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    30603
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0464-05
  • Fecha de inicio del evento
    2004-12-03
  • Fecha de publicación del evento
    2005-02-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36199
  • 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
    Set, Administration, Intravascular - Product Code FPA
  • Causa
    Administration sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate.
  • Acción
    Customers were sent a product Safety & Recall notification via email or regular mail begining 12/03/04 through 12/08/04. A Product Recall form requested the customer for feedback as to Quantity Used, Quantity to be Retained and Quantity to be returned . The Customer Recall Notication states that if no Administration Sets from alternative lots are available and the use of the volumetric pump is essential, follow the instructions in the attached Customer Information Bulletin, which describes how to identify a set which does not have the defect. Customers who find product subject to the recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths.
Retiro De Equipo (Recall) de Device Recall LogixCM Compounder Software
  • Tipo de evento
    Recall
  • ID del evento
    30609
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0392-05
  • Fecha de inicio del evento
    2004-12-08
  • Fecha de publicación del evento
    2004-12-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36209
  • 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
    Set, I.V. Fluid Transfer - Product Code LHI
  • Causa
    A software anomaly in the logix cm software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in logix and another order entry program being used with the logix software.
  • Acción
    Urgent Device Correction letters dated 12/8/04 were sent to the end users via overnight mail. The accounts were informed of the potential for omission of an ingredient if there are duplicate drug Id''s in the order, and were requested to complete and fax the customer reply form to Baxter at 847-270-5457, indicating if they are currently using Logix-CM software. Upon receipt of the reply form, Baxter will schedule a visit to the facility to examine the base and additive inventory information in their MOS database to confirm that there are no duplicate Drug ID numbers and that this issue has not occurred at the facility. They will also secure the MOS database to ensure that the situation will not be able to occur. Any questions were directed to Baxter Clintec Nutrition, option 1, at 1-800-422-2751.
Retiro De Equipo (Recall) de Device Recall Aortic cannula
  • Tipo de evento
    Recall
  • ID del evento
    30623
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0306-05
  • Fecha de inicio del evento
    2004-11-19
  • Fecha de publicación del evento
    2004-12-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-01-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36226
  • 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
    Aortic cannula may delaminate and leak where it is bonded to the tip. this could occur during cardiopulmonary bypass surgery.
  • Acción
    All consignees were notified by letter on 11/22/2004
Retiro De Equipo (Recall) de Device Recall Advanced DDimer
  • Tipo de evento
    Recall
  • ID del evento
    30634
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0538-05
  • Fecha de inicio del evento
    2004-12-03
  • Fecha de publicación del evento
    2005-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-10-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36243
  • 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
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
  • Causa
    Decrease in product stability after reconstitution and reduced stability on board certain instrument systems.
  • Acción
    The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.
Retiro De Equipo (Recall) de Device Recall Guiding Catheter
  • Tipo de evento
    Recall
  • ID del evento
    30637
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0434-05
  • Fecha de inicio del evento
    2004-12-07
  • Fecha de publicación del evento
    2005-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36253
  • 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, Percutaneous - Product Code DQY
  • Causa
    Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'rdc' shape rather than the 'rdc(1)' shape. the rdc shape has a larger curve. the product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process.
  • Acción
    Packets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form.
Retiro De Equipo (Recall) de Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 80...
  • Tipo de evento
    Recall
  • ID del evento
    30639
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0418-05
  • Fecha de inicio del evento
    2003-05-21
  • Fecha de publicación del evento
    2005-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-01-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36254
  • 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
    Applier, Surgical, Clip - Product Code GDO
  • Causa
    Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.
  • Acción
    Consignees were notified by letter sent via Federal Express on/about 05/21/2003.
Retiro De Equipo (Recall) de Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet...
  • Tipo de evento
    Recall
  • ID del evento
    30641
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0340-05
  • Fecha de inicio del evento
    2001-01-25
  • Fecha de publicación del evento
    2004-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36256
  • 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
    Cord, Electric, For Endoscope - Product Code FFZ
  • Causa
    An incorrect electrosurgical cord was included in some of the packages.
  • Acción
    Consignees were notified by letter sent Federal Express on 01/25/2001.
Retiro De Equipo (Recall) de Device Recall AMPLATZER Delivery Systems
  • Tipo de evento
    Recall
  • ID del evento
    30481
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0351-05
  • Fecha de inicio del evento
    2004-11-23
  • Fecha de publicación del evento
    2004-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36263
  • 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
    unknown device name - Product Code GBK
  • Causa
    Tubing utilized in the manufacture of the amplatzer delivery and exchange system sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
  • Acción
    Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical.
Retiro De Equipo (Recall) de Device Recall Soft Contact Lens
  • Tipo de evento
    Recall
  • ID del evento
    30647
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0348-05
  • Fecha de inicio del evento
    2004-12-09
  • Fecha de publicación del evento
    2004-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36264
  • 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
    Lenses, Soft Contact, Daily Wear - Product Code LPL
  • Causa
    Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
  • Acción
    All consignees were notified by courier on 12/09/2004.
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.