• 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 514
  • Fabricante 58
  • Evento 124969
  • Implante 1
Retiro De Equipo (Recall) de VITEK 2 AST P586
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2358-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155072
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P592
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2359-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155073
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P597
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2360-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155074
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P606
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2365-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155082
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de SpFPLUS Implantable Stimulator
  • Tipo de evento
    Recall
  • ID del evento
    77089
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2119-2017
  • Fecha de inicio del evento
    2017-04-20
  • Estado del evento
    Completed
  • 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=155075
  • 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
    Stimulator, invasive bone growth - Product Code LOE
  • Causa
    Zimmer biomet is conducting a medical device field action for the spf plus-mini and spf xl iib implantable spinal fusion stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
  • Acción
    An Urgent Medical Device Recall letter, dated April 20, 2017, was sent to the firm's consignees. The letter identified the affected product and the reason for the recall, as well as the risks involved. Consignees were instructed to quarantine affected product in their inventory and complete the Certification of Acknowledgement portion and the Inventory Return Certification Form in the letter. Affected product must be returned immediately along with the completed Inventory Return Certification Form. Questions or concerns should be directed to the customer call center at 1-800-447-3625 or via email to corporatequality.postmarket@zimmerbiomet.com.
Retiro De Equipo (Recall) de VITEK 2 AST GP69
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2361-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155077
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P600
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2362-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155078
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P603
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2363-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155079
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de Negative Pressure Wound Therapy Systems
  • Tipo de evento
    Recall
  • ID del evento
    77159
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2171-2017
  • Fecha de inicio del evento
    2017-04-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155080
  • 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
    negative pressure wound therapy Powered suction pump - Product Code OMP
  • Causa
    Potential sterile barrier breach.
  • Acción
    KCI sent an Urgent Voluntary Medical Device Field Notification letter to all affected consignees on April 28, 2017. KCI will monitor return of the Customer Reconciliation Forms to ensure compliance with the Field Notification. Customers were instructed locate and quarantine any of the affected product, complete Acknowledgement form and email to RegulatoryCompliance@acelity.com or fax to 210-255-6727. Customers with questions were advised to contact their local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected product.. For questions regarding this recall call 210-515-4108.
Retiro De Equipo (Recall) de VITEK 2 AST P605
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2364-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155081
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de IBC FloProbe
  • Tipo de evento
    Recall
  • ID del evento
    35704
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1223-06
  • Fecha de inicio del evento
    2005-04-22
  • Fecha de publicación del evento
    2006-07-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46643
  • 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
    Probe, Blood-Flow, Extravascular - Product Code DPT
  • Causa
    Complaints received regarding the device's failure to zero out.
  • Acción
    Firm notified customers via e-mail and phone calls starting on 04/22/05.
Retiro De Equipo (Recall) de VITEK 2 AST GN38
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2366-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155083
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P607
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2367-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155084
  • 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, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P608
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2368-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155085
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P612
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2369-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155086
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST XN01
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2370-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155087
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P613
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2371-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155088
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST ST01
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2372-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155089
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P616
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2373-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155090
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST XN04
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2374-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155091
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST GP71
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2375-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155092
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P618
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2376-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155093
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST P619
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2377-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155094
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST YS05
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2378-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155095
  • 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
    Susceptibility test plate, antifungal - Product Code NGZ
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
Retiro De Equipo (Recall) de VITEK 2 AST GN48
  • Tipo de evento
    Recall
  • ID del evento
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2379-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=155096
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
  • « First
  • ‹ Prev
  • 1
  • 2
  • 3
  • 4
  • 5
  • …
  • 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)