• 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 25
  • Fabricante 5
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Diagnostic Ultrasound Unit
  • Tipo de evento
    Recall
  • ID del evento
    47253
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1571-2008
  • Fecha de inicio del evento
    2008-02-25
  • Fecha de publicación del evento
    2008-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69117
  • 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
    Radiation Therapy System - Product Code LHN
  • Causa
    Miscalculation reading. a software error in the firm's eub-5500/hi vision diagnostic scanning system causes a miscalculation of the left ica/cca ratio when using the carotid calculation package for patient scans.
  • Acción
    A Device Correction Letter was issue by the firm on 02/25/2008. The letter asks the affected customers not to use the value of ICA/CCA on the Measurement Report for diagnosis, but instead to follow the Immediate countermeasure detailed in the 'Note in Use' document which accompanies the Device Correction letter. The customers are asked to follow the Immediate Countermeasure until they receive a Temporary Countermeasure to correct the ICA/CCA ratio calculation. The Temporary Countermeasure will include: 1) a Disk to import a new carotid measure package; 2) an Installation booklet detailing how to import the new carotid measurement package and optional customization tools; and 3) an Operator manual addendum Upon release of the countermeasure, the firm's Applications or Servcie personnel shall perform the corrective action as identified in the Service Pack (A) Installation Instructions. Finally, upon release of the next software revision, service personnel will replace the software at each customer location.
Retiro De Equipo (Recall) de Device Recall Alaris Medley Pump Module
  • Tipo de evento
    Recall
  • ID del evento
    47335
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1710-2008
  • Fecha de inicio del evento
    2008-03-05
  • Fecha de publicación del evento
    2008-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69241
  • 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
    Infusion Pump - Product Code FRN
  • Causa
    A channel error on an affected alaris system module will stop an active infusion (or monitoring) with an audible and visual alarm. channel errors due to failures of the u19 socketed integrated circuits (u19 ic) on the logic board of the alaris pump module ("pump module"). the user will be required to replace the affected module.
  • Acción
    An Urgent Medical Device Recall Notification letter was sent to consignees on April 10, 2008. Four customer letters were issued. The U19 IC issue affects only the Pump module and the U9 IC issue affects only the Syringe and PCA modules. Therefore there will be one letter for customers affected by all three issues Ul9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted through consignees (distributors as well as direct customers for the affected devices). Distributors will be sent multiple copies of the Recall Notification and Customer Response Cards. The Recall letters all includeRequired Actions sections which give their customers specific information about the issue and what the customers are to do and includes a web site link for each specific problem. Each recall letter also has chart of Cardinal Health contacts support.
Retiro De Equipo (Recall) de Device Recall Alaris Medley 8000,8100, 8110,8120,8210 and, 8220
  • Tipo de evento
    Recall
  • ID del evento
    47335
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1711-2008
  • Fecha de inicio del evento
    2008-03-05
  • Fecha de publicación del evento
    2008-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69242
  • 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
    Infusion Pump - Product Code FRN
  • Causa
    A channel error on an affected alaris system module will stop an active infusion (or monitoring) with an audible and visual alarm. channel errors with the alaris system due to the inter-unit interface (iui) connectors on all alaris system modules (manufactured on or before march 26, 2004). grey inter-unit interface connectors ("iui") on the following alaris system modules built on or before march.
  • Acción
    An Urgent Medical Device Recall Notification letter was sent to consignees on April 10, 2008. Four customer letters were issued. The U19 IC issue affects only the Pump module and the U9 IC issue affects only the Syringe and PCA modules. Therefore there will be one letter for customers affected by all three issues Ul9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted through consignees (distributors as well as direct customers for the affected devices). Distributors will be sent multiple copies of the Recall Notification and Customer Response Cards. The Recall letters all includeRequired Actions sections which give their customers specific information about the issue and what the customers are to do and includes a web site link for each specific problem. Each recall letter also has chart of Cardinal Health contacts support.
Retiro De Equipo (Recall) de Device Recall BIOMET 3i Locator Abutment
  • Tipo de evento
    Recall
  • ID del evento
    47340
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1363-2008
  • Fecha de inicio del evento
    2008-02-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69245
  • 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
    Locator Abutment - Product Code DZE
  • Causa
    Mispackaging: the locator abutment labeled as loa002 may contain catalog/item # loa003 product and visa versa.
  • Acción
    Each USA customer was contacted by telephone and then by letter, Urgent Medical Device Recall, dated 2/15/2008, sent by fax. International customers were first contacted by E-mail then by fax letter also. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory for product return. They were also instructed to return the affected product to Biomet 3i.
Retiro De Equipo (Recall) de Device Recall Calf Garment
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1666-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69254
  • 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
    Compression garment - Product Code JOW
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Certain MicroMiniplant Straight Healing Abutment
  • Tipo de evento
    Recall
  • ID del evento
    47341
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1365-2008
  • Fecha de inicio del evento
    2008-02-06
  • Fecha de publicación del evento
    2008-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69247
  • 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
    Healing Abutment - Product Code NHA
  • Causa
    Seating problems: the micro-miniplant straight healing abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.
  • Acción
    USA customers were contacted by telephone with a follow-up fax. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i.
Retiro De Equipo (Recall) de Device Recall Emergence Profile (EP) Healing Abutment
  • Tipo de evento
    Recall
  • ID del evento
    47342
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1366-2008
  • Fecha de inicio del evento
    2008-02-14
  • Fecha de publicación del evento
    2008-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69248
  • 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
    Profile Healing Abutment - Product Code NHA
  • Causa
    Mis-labeling: labeled tha53 device packaging may contain itha53 devices (the itha53 is designed to be used with an internally hexed implant--the tha53 is used with an external hex platform).
  • Acción
    Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.
Retiro De Equipo (Recall) de Device Recall Calf Garmet
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1661-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69249
  • 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
    Compression garmet - Product Code JOW
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Zimmer Tourniquet Cuff
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1662-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69250
  • 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
    Pneumatic Tourniquet - Product Code KCY
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Neonatal/Adult 02 Transducer
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1663-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69251
  • 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
    Pulse Oximeter - Product Code NLF
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Adult 02 Transducer
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1664-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69252
  • 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
    Pulse Oximeter - Product Code NLF
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Foot Garment
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1665-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69253
  • 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
    Compression garment - Product Code JOW
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Side Effect Electrode
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1667-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69255
  • 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
    Arthroscopic Electrode - Product Code HRX
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Right Angle Arthrowand
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1668-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69256
  • 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
    Arthroscopic wand - Product Code HRX
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Suction Wand
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1669-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69257
  • 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
    Arthroscopic wand - Product Code HRX
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Angled Side Effect Electrode
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1670-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69258
  • 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
    Arthroscopic wand - Product Code HRX
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Thigh Garment
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1671-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69259
  • 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
    Compression garment - Product Code JOW
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Foot Garment
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1672-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69260
  • 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
    Compression garment - Product Code JOW
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Tourniquet Cuff Single Port Single Bladder
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1673-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69261
  • 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
    Pneumatic Tourniquet - Product Code KCY
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Medical Suture Passer
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1674-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69262
  • 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
    Suture passer - Product Code NLM
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Stablecut Saw Blade
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1675-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69263
  • 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
    Saw - Product Code HAB
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Thigh Garment
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1676-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69264
  • 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
    Compression garment - Product Code JOW
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Oscillating & Sagittal Blade
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1677-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69265
  • 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
    Saw blade - Product Code HAB
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall Color Cuff II, Double Port Single Bladder
  • Tipo de evento
    Recall
  • ID del evento
    47343
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1678-2008
  • Fecha de inicio del evento
    2008-03-11
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69266
  • 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
    Pneumatic tourniquet - Product Code KCY
  • Causa
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Acción
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Retiro De Equipo (Recall) de Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System
  • Tipo de evento
    Recall
  • ID del evento
    47347
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1556-2008
  • Fecha de inicio del evento
    2008-03-10
  • Fecha de publicación del evento
    2008-07-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69267
  • 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
    Iliac Stent - Product Code NIO
  • Causa
    Data transcription error. the 10 affected lots of catalog number c10040sl were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. this condition may result in a separation of the device. if a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel.
  • Acción
    A letter (RE: Medical Device Recall) dated March 11, 2008, and Acknowledgement Form was sent overnight to the following 6 individuals in each account: Dir. Cardiac Cath Lab, Dir. Radiology Services, Dir. Vascular Services, Risk Manager, Materials Dir., Hospital Administrator; requesting that the affected product be set aside, and that the form be reviewed, signed, and faxed back to Cordis. Affected product is to be either returned or the local sales rep should the contacted to facilitate the return of the affected product. All product will be replaced. Customer Service can be contacted if there are additional questions relative to product return, replacement, or availability.
  • 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.

Descargar la data

La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

Descargar todo (zipped)