• 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 1
  • Fabricante 1
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F C...
  • Tipo de evento
    Recall
  • ID del evento
    79841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1766-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163717
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
  • Acción
    The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Retiro De Equipo (Recall) de Device Recall POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 8F C...
  • Tipo de evento
    Recall
  • ID del evento
    79841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1767-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163718
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
  • Acción
    The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Retiro De Equipo (Recall) de Device Recall POWERPORT(R) ClearVUE(R) Slim with Smooth Septum, 6F ...
  • Tipo de evento
    Recall
  • ID del evento
    79841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1768-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163719
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
  • Acción
    The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Retiro De Equipo (Recall) de Device Recall POWERPORT(R) ClearVUE(R) Slim with Smooth Septum, 6F ...
  • Tipo de evento
    Recall
  • ID del evento
    79841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1769-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163720
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
  • Acción
    The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Retiro De Equipo (Recall) de Device Recall POWERPORT(R) ClearVUE(R) Slim with Smooth Septum, 8F ...
  • Tipo de evento
    Recall
  • ID del evento
    79841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1770-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163721
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
  • Acción
    The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Retiro De Equipo (Recall) de Device Recall POWERPORT(R) ClearVUE(R) Slim with Smooth Septum, 8F ...
  • Tipo de evento
    Recall
  • ID del evento
    79841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1771-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163722
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
  • Acción
    The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Retiro De Equipo (Recall) de Device Recall POWERPORT(R) ClearVUE(R) isp Implantable Port With Sm...
  • Tipo de evento
    Recall
  • ID del evento
    79841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1772-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163723
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
  • Acción
    The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Retiro De Equipo (Recall) de Device Recall POWERPORT(R) ClearVUE(R) Slim Implantable Port with S...
  • Tipo de evento
    Recall
  • ID del evento
    79841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1773-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163724
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
  • Acción
    The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Retiro De Equipo (Recall) de Device Recall iChem(R) VELOCITY Urine Chemistry Strips
  • Tipo de evento
    Recall
  • ID del evento
    79857
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1893-2018
  • Fecha de inicio del evento
    2017-12-04
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163764
  • 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
    Test, urine leukocyte - Product Code LJX
  • Causa
    A subset of lot 7212154 a of the ichem velocity urine chemistry strips has an incorrect pad placed in the location of the leukocytes pad. this will result in control cb failure for leukocytes and may generate false negative erroneous results for leukocytes.
  • Acción
    The firm initiated the recall by letter on 12/04/2017. The letter identified the affected product, problem and the actions to be taken. The firm requested destruction of the recalled product.
Retiro De Equipo (Recall) de Device Recall Ondamed Biofeedback Device
  • Tipo de evento
    Recall
  • ID del evento
    79858
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1782-2018
  • Fecha de inicio del evento
    2017-07-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163767
  • 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
    Device, biofeedback - Product Code HCC
  • Causa
    The firm was marketing the ondamed system in the us without marketing clearance. as a corrective action, the firm revised its device design to comply with regulations. the firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content spo2.
  • Acción
    On July 7, 2017, the firm notified affected customers that the firm had made design changes to the Ondamed Biofeedback System. Customers were asked to contact the firm as soon as possible to make arrangements to return their devices for upgrade. Customers may contact the firm at 1-845-534-0456, or by email at support@ondamed.net. For further questions, please call (845) 496-6673.
Retiro De Equipo (Recall) de Device Recall INSPIRE 6 hollow fiber oxygenator with integrated har...
  • Tipo de evento
    Recall
  • ID del evento
    79863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1918-2018
  • Fecha de inicio del evento
    2018-03-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163774
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Causa
    Some integrated sterile inspire family products contain an incorrect expiration date printed in the unique device identification (udi) bar code and readable code just beneath the barcode. specifically, the expiration date is reported as ddmmyy instead of yymmdd. the expiration date in the applicable field on the package labels are correct as printed.
  • Acción
    On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.
Retiro De Equipo (Recall) de Device Recall Monitor, Physiological, Patient (with Arrhythmia Dete...
  • Tipo de evento
    Recall
  • ID del evento
    79871
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1813-2018
  • Fecha de inicio del evento
    2018-03-28
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163782
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    Software anomaly resulting in the loss of patient settings and stored patient data.
  • Acción
    On March 28, 2018, Drager Medical Systems Inc. mailed Urgent Medical Device Recall Notifications to affected customers. The following information was included in the notification: 1) Do not use Infinity MCable Mainstream CO2 sensors revision 16 with M540 Patient Monitor, software versions VG4.1 or lower. Previous revisions of the CO2 sensor may be used. 2) We are in process of resolving this product issue. If you choose to upgrade your system(s), your Dr¿ger service representative will schedule a service visit and upgrade your M540 patient monitor(s) once the updated software is available for distribution. 3)A Customer Reply Card will be included as a receipt from the customers that they received this information and to indicate if the customer would like the revised software update once it is available. Customer with questions regarding the notification may call (800) 437-2437 (press 1 at the prompt, then 32349) Customers with questions regarding the operation and/or servicing of the Drager Infinity Acute Care System may contact Drager Service Technical Support at (800) 437-2437 (press 4 at the prompt then 4 again).
Retiro De Equipo (Recall) de Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert
  • Tipo de evento
    Recall
  • ID del evento
    79875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1904-2018
  • Fecha de inicio del evento
    2018-03-30
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163793
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
  • Acción
    The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
Retiro De Equipo (Recall) de Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert
  • Tipo de evento
    Recall
  • ID del evento
    79875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1905-2018
  • Fecha de inicio del evento
    2018-03-30
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163794
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
  • Acción
    The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
Retiro De Equipo (Recall) de Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert
  • Tipo de evento
    Recall
  • ID del evento
    79875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1906-2018
  • Fecha de inicio del evento
    2018-03-30
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163795
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
  • Acción
    The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
Retiro De Equipo (Recall) de Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert
  • Tipo de evento
    Recall
  • ID del evento
    79875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1907-2018
  • Fecha de inicio del evento
    2018-03-30
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163796
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
  • Acción
    The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
Retiro De Equipo (Recall) de Device Recall INSPIRE 8 hollow fiber oxygenator with integrated har...
  • Tipo de evento
    Recall
  • ID del evento
    79863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1919-2018
  • Fecha de inicio del evento
    2018-03-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163800
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Causa
    Some integrated sterile inspire family products contain an incorrect expiration date printed in the unique device identification (udi) bar code and readable code just beneath the barcode. specifically, the expiration date is reported as ddmmyy instead of yymmdd. the expiration date in the applicable field on the package labels are correct as printed.
  • Acción
    On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.
Retiro De Equipo (Recall) de Device Recall MagNA Pure 24 System Pathogen Protocols
  • Tipo de evento
    Recall
  • ID del evento
    79899
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1956-2018
  • Fecha de inicio del evento
    2018-05-02
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163850
  • 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
    Clinical sample concentrator - Product Code JJH
  • Causa
    Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
  • Acción
    Customers were notified of the field action by letter on 4/27/18. The letter included the following required actions: " If you used the MagNA Pure 24 Pathogen 200 and/or Pathogen 1000 protocols to extract nucleic acids for an assay for a chronic infectious disease (e.g., Hepatitis C Virus), then suspected false positives should be evaluated further following local procedures and retested as necessary. " Complete the attached fax form and fax it to 1-844-861-6232 or email it to roche6612@stericycle.com. " File this Urgent Medical Device Correction (UMDC) for future reference.
Retiro De Equipo (Recall) de Device Recall Jasper Vektor
  • Tipo de evento
    Recall
  • ID del evento
    79739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1784-2018
  • Fecha de inicio del evento
    2018-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163877
  • 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
    Spring, orthodontic - Product Code ECO
  • Causa
    The firm has received 106 complaints of the device breaking in the patient's mouth. device breakage may cause injury to the patient.
  • Acción
    On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or info@tportho.com for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: info@tportho.com FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or info@tportho.com
Retiro De Equipo (Recall) de Device Recall Jasper Vektor
  • Tipo de evento
    Recall
  • ID del evento
    79739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1785-2018
  • Fecha de inicio del evento
    2018-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163878
  • 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
    Spring, orthodontic - Product Code ECO
  • Causa
    The firm has received 106 complaints of the device breaking in the patient's mouth. device breakage may cause injury to the patient.
  • Acción
    On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or info@tportho.com for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: info@tportho.com FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or info@tportho.com
Retiro De Equipo (Recall) de Device Recall Jasper Vektor
  • Tipo de evento
    Recall
  • ID del evento
    79739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1786-2018
  • Fecha de inicio del evento
    2018-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163879
  • 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
    Spring, orthodontic - Product Code ECO
  • Causa
    The firm has received 106 complaints of the device breaking in the patient's mouth. device breakage may cause injury to the patient.
  • Acción
    On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or info@tportho.com for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: info@tportho.com FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or info@tportho.com
Retiro De Equipo (Recall) de Device Recall WetField Hemostatic Eraser Bipolar 25G
  • Tipo de evento
    Recall
  • ID del evento
    79915
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1801-2018
  • Fecha de inicio del evento
    2018-02-26
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163934
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Products were packaged with incorrect labeling,.
  • Acción
    On 2/26/18 Beaver-Visitec emailed product recall notices to affected customers. Customers were instructed to destroy the affected product, provide objective evidence of the product destruction, then complete and return the customer response form. Customers with questions regarding this recall may contact Customer Service at (866)906-8080.
Retiro De Equipo (Recall) de Device Recall Jasper Vektor
  • Tipo de evento
    Recall
  • ID del evento
    79739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1787-2018
  • Fecha de inicio del evento
    2018-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163880
  • 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
    Spring, orthodontic - Product Code ECO
  • Causa
    The firm has received 106 complaints of the device breaking in the patient's mouth. device breakage may cause injury to the patient.
  • Acción
    On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or info@tportho.com for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: info@tportho.com FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or info@tportho.com
Retiro De Equipo (Recall) de Device Recall Jasper Vektor
  • Tipo de evento
    Recall
  • ID del evento
    79739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1788-2018
  • Fecha de inicio del evento
    2018-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163881
  • 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
    Spring, orthodontic - Product Code ECO
  • Causa
    The firm has received 106 complaints of the device breaking in the patient's mouth. device breakage may cause injury to the patient.
  • Acción
    On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or info@tportho.com for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: info@tportho.com FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or info@tportho.com
Retiro De Equipo (Recall) de Device Recall Jasper Vektor
  • Tipo de evento
    Recall
  • ID del evento
    79739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1789-2018
  • Fecha de inicio del evento
    2018-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163882
  • 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
    Spring, orthodontic - Product Code ECO
  • Causa
    The firm has received 106 complaints of the device breaking in the patient's mouth. device breakage may cause injury to the patient.
  • Acción
    On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or info@tportho.com for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: info@tportho.com FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or info@tportho.com
  • First
  • Previous
  • 1
  • 2
  • 3
  • 4
  • Truncate
  • 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)