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  • Dispositivo 1
  • Fabricante 1
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Flexxus
  • Tipo de evento
    Recall
  • ID del evento
    37628
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0729-2007
  • Fecha de inicio del evento
    2007-03-14
  • Fecha de publicación del evento
    2007-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51132
  • 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
    Endoscopic Biliary Stent - Product Code FGE
  • Causa
    Blue safety clip incorrectly placed on the stent may prevent deployment.
  • Acción
    ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
Retiro De Equipo (Recall) de Device Recall Flexxus
  • Tipo de evento
    Recall
  • ID del evento
    37628
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0730-2007
  • Fecha de inicio del evento
    2007-03-14
  • Fecha de publicación del evento
    2007-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51134
  • 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
    Endoscopic Biliary Stent, - Product Code FGE
  • Causa
    Blue safety clip incorrectly placed on the stent may prevent deployment.
  • Acción
    ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
Retiro De Equipo (Recall) de Device Recall DiaSorin 1,25Dihydroxyvitamin D RIA Kit
  • Tipo de evento
    Recall
  • ID del evento
    37632
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0707-2007
  • Fecha de inicio del evento
    2006-06-05
  • Fecha de publicación del evento
    2007-04-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51186
  • 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
    1,25-Dihydroxyvitamin D RIA Kit - Product Code MRG
  • Causa
    Potential for the diasorin kit 1,25-dihydroxyvitamin d ria kit control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, low. (if one or both of the kit controls recover outside the defined range, the run is considered invalid).
  • Acción
    Product recalled by letter dated 6/01/2006
Retiro De Equipo (Recall) de Device Recall Rely X
  • Tipo de evento
    Recall
  • ID del evento
    37635
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0800-2007
  • Fecha de inicio del evento
    2007-02-12
  • Fecha de publicación del evento
    2007-05-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51189
  • 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
    Dental Cement - Product Code EBF
  • Causa
    Cement in 3m espe relyx veneer cement refill a3 shade syringes, may not cure to the degree expected.
  • Acción
    All consignees including distributors were notified of the recall via telephone or mail on 2/27/2007. Communication with distributors included the product being recalled, the problem , recommended stop usage or distribution and directions for return shippment. Further, the consignees were also sent a letter which described the product and problem and what to do if the product was still availabe or had been used.
Retiro De Equipo (Recall) de Device Recall OEC FluoroTrak Plus 9800
  • Tipo de evento
    Recall
  • ID del evento
    37322
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0557-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51194
  • 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
    Image-intensified fluoroscopic x-ray system. - Product Code JAA
  • Causa
    During routine service, a cover may have been installed without the required proper lead shielding.
  • Acción
    Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
Retiro De Equipo (Recall) de Device Recall OEC 9800 Plus
  • Tipo de evento
    Recall
  • ID del evento
    37322
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0558-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51195
  • 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
    Image-intensified fluoroscopic x-ray system. - Product Code JAA
  • Causa
    During routine service, a cover may have been installed without the required proper lead shielding.
  • Acción
    Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
Retiro De Equipo (Recall) de Device Recall OEC 9800MD
  • Tipo de evento
    Recall
  • ID del evento
    37322
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0559-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51196
  • 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
    Image-intensified fluoroscopic x-ray system. - Product Code JAA
  • Causa
    During routine service, a cover may have been installed without the required proper lead shielding.
  • Acción
    Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
Retiro De Equipo (Recall) de Device Recall Urologix Targis
  • Tipo de evento
    Recall
  • ID del evento
    37638
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0720-2007
  • Fecha de inicio del evento
    2007-03-16
  • Fecha de publicación del evento
    2007-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-05-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51198
  • 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
    Microwave Delivery System - Product Code MEQ
  • Causa
    The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
  • Acción
    A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.
Retiro De Equipo (Recall) de Device Recall MacLab
  • Tipo de evento
    Recall
  • ID del evento
    37640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1132-2007
  • Fecha de inicio del evento
    2007-02-16
  • Fecha de publicación del evento
    2007-08-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51202
  • 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
    cardiac catheterization data system - Product Code DQK
  • Causa
    Ge healthcare has identified conditions that could cause a potential loss of real-time monitoring with the cardiolab/mac-lab/combolab electrophysiology and hemodynamic monitoring systems. these issues are associated with an audio driver, and the use of the application's log and imaging windows.
  • Acción
    Consignees were sent a letter dated 2/16/07. The letter described the product and problem, made recommendations and gave information on software update.
Retiro De Equipo (Recall) de Device Recall CardioLab
  • Tipo de evento
    Recall
  • ID del evento
    37640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1133-2007
  • Fecha de inicio del evento
    2007-02-16
  • Fecha de publicación del evento
    2007-08-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51203
  • 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
    electrophysiological data system - Product Code DQK
  • Causa
    Ge healthcare has identified conditions that could cause a potential loss of real-time monitoring with the cardiolab/mac-lab/combolab electrophysiology and hemodynamic monitoring systems. these issues are associated with an audio driver, and the use of the application's log and imaging windows.
  • Acción
    Consignees were sent a letter dated 2/16/07. The letter described the product and problem, made recommendations and gave information on software update.
Retiro De Equipo (Recall) de Device Recall Sunrise MedicalHoyer Advance Patient Lifts
  • Tipo de evento
    Recall
  • ID del evento
    37641
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0727-2007
  • Fecha de inicio del evento
    2007-02-21
  • Fecha de publicación del evento
    2007-04-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51204
  • 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
    Patient Lift - Product Code FSA
  • Causa
    Unapproved design change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).
  • Acción
    Recall initiated by letter dated 2/21/2007. Sunrise Medical will schedule onsite appointments to complete the base replacement.
Retiro De Equipo (Recall) de Device Recall QRS Card 12 Lead Resting & Stress ECG Machine with Bl...
  • Tipo de evento
    Recall
  • ID del evento
    37642
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0716-2007
  • Fecha de inicio del evento
    2007-03-05
  • Fecha de publicación del evento
    2007-04-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51207
  • 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
    electrocardiogram machine - Product Code LOS
  • Causa
    No 510(k) marketing clearance for the product.
  • Acción
    On 3/5/07, the recalling firm telephoned their customers to inform them of the problem and the need to return to the product. As a follow up to the telephone calls a letter dated 3/5/07 was sent via certified mail.
Retiro De Equipo (Recall) de Device Recall Diamond Mammographic XRay System
  • Tipo de evento
    Recall
  • ID del evento
    37651
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0976-2007
  • Fecha de inicio del evento
    2005-11-16
  • Fecha de publicación del evento
    2007-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51225
  • 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
    Mammographic X-Ray System - Product Code IZH
  • Causa
    Ge healthcare has become aware of the absence of thread-locking compound associated with the c-arm fasteners of your diamond mammographic x-ray system that may impact patient safety.
  • Acción
    A Product Safety Notification, dated 05/24/07, was sent to Hospital Administrators, Managers of Radiology and Radiologists. This letter describes the safety issue, instructions to continue the use of the product and states that the device will be corrected by GE Healthcare service engineers.
Retiro De Equipo (Recall) de Device Recall EXCITE
  • Tipo de evento
    Recall
  • ID del evento
    37653
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0815-2007
  • Fecha de inicio del evento
    2006-06-01
  • Fecha de publicación del evento
    2007-05-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51228
  • 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
    Magnetic Resonance System - Product Code LNH
  • Causa
    To provide the 3.0t mri systems users with the 8-channel brain coil the proper coil weighting software. the proper coil weighting factors for the eight-channel brain coil were not included in the software.
  • Acción
    The corrective action is already completed and all customers have been notified via a personal visit to each site, to install a software patch beginning June, 2006.
Retiro De Equipo (Recall) de Device Recall Revolution XR/d
  • Tipo de evento
    Recall
  • ID del evento
    37654
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1788-2012
  • Fecha de inicio del evento
    2006-05-31
  • Fecha de publicación del evento
    2012-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51229
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a proteus xr/a table while moving the tabletop with the thumb placed over its edge and fingers underneath.
  • Acción
    GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.
Retiro De Equipo (Recall) de Device Recall Definium 8000
  • Tipo de evento
    Recall
  • ID del evento
    37654
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1789-2012
  • Fecha de inicio del evento
    2006-05-31
  • Fecha de publicación del evento
    2012-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51230
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a proteus xr/a table while moving the tabletop with the thumb placed over its edge and fingers underneath.
  • Acción
    GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.
Retiro De Equipo (Recall) de Device Recall Silhouette FC (currently marketed as Proteus XR/a)
  • Tipo de evento
    Recall
  • ID del evento
    37654
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1790-2012
  • Fecha de inicio del evento
    2006-05-31
  • Fecha de publicación del evento
    2012-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51231
  • 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
    System, x-ray, stationary - Product Code KPR
  • Causa
    An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a proteus xr/a table while moving the tabletop with the thumb placed over its edge and fingers underneath.
  • Acción
    GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.
Retiro De Equipo (Recall) de Device Recall InstaTrak 3500 Plus
  • Tipo de evento
    Recall
  • ID del evento
    37661
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0181-2008
  • Fecha de inicio del evento
    2007-03-23
  • Fecha de publicación del evento
    2007-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51247
  • 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
    Image Processing Radiological System - Product Code LLZ
  • Causa
    Tracking accuracy - image intensifier supplier's change on the c-arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.
  • Acción
    Consignees were sent an Urgent Recall Notice letter, via mail dated 10/11/07, advising users to stop usage of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus System. Once a solution is identified, a representative will contact consignees to arrange for installation of the solution at no charge.
Retiro De Equipo (Recall) de Device Recall Uroglogix Targis
  • Tipo de evento
    Recall
  • ID del evento
    37638
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0721-2007
  • Fecha de inicio del evento
    2007-03-16
  • Fecha de publicación del evento
    2007-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-05-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51251
  • 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
    Microwave Delivery System - Product Code MEQ
  • Causa
    The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
  • Acción
    A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.
Retiro De Equipo (Recall) de Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 0
  • Tipo de evento
    Recall
  • ID del evento
    37665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0857-2007
  • Fecha de inicio del evento
    2007-03-23
  • Fecha de publicación del evento
    2007-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51254
  • 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
    CPAP - Product Code BZD
  • Causa
    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
  • Acción
    Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Retiro De Equipo (Recall) de Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 1
  • Tipo de evento
    Recall
  • ID del evento
    37665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0858-2007
  • Fecha de inicio del evento
    2007-03-23
  • Fecha de publicación del evento
    2007-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51255
  • 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
    CPAP - Product Code BZD
  • Causa
    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
  • Acción
    Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Retiro De Equipo (Recall) de Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 2
  • Tipo de evento
    Recall
  • ID del evento
    37665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0859-2007
  • Fecha de inicio del evento
    2007-03-23
  • Fecha de publicación del evento
    2007-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51257
  • 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
    CPAP - Product Code BZD
  • Causa
    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
  • Acción
    Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Retiro De Equipo (Recall) de Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 3
  • Tipo de evento
    Recall
  • ID del evento
    37665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0860-2007
  • Fecha de inicio del evento
    2007-03-23
  • Fecha de publicación del evento
    2007-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51258
  • 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
    CPAP - Product Code BZD
  • Causa
    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
  • Acción
    Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Retiro De Equipo (Recall) de Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 4
  • Tipo de evento
    Recall
  • ID del evento
    37665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0861-2007
  • Fecha de inicio del evento
    2007-03-23
  • Fecha de publicación del evento
    2007-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51259
  • 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
    CPAP - Product Code BZD
  • Causa
    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
  • Acción
    Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Retiro De Equipo (Recall) de Device Recall Synovis PetriStrips Dry with Veritas Collagen Matrix ...
  • Tipo de evento
    Recall
  • ID del evento
    37671
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0960-2007
  • Fecha de inicio del evento
    2007-03-16
  • Fecha de publicación del evento
    2007-06-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51278
  • 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
    Surgical Mesh - Product Code FTM
  • Causa
    Package integrity/sterility compromised: the foil pouch in the peri-strips dry with veritas collagen matrix circular staple line reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
  • Acción
    Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.
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