Events

Notificaciones De Seguridad De Campo acerca de ARROW® PICC

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Arrow International Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2015-07-31
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Arrow will recall certain product serial numbers listed above to allow the removable tabs of the catheter joint to be separated prematurely when the physician begins to remove the catheter sleeve. although the problem poses no greater risk to the patient, it may delay treatment when inserting the catheter. arrow recalls these products to provide customers and patients with the highest quality products.

Device

ARROW® PICC
  • Modelo / Serial
    ASK‐02041‐SEH1 CA‐05052‐HP CDC‐34052‐VPS EU‐05552‐HPMSB ASK‐04001‐DU4 CA‐05052‐HPX CDC‐35041‐VPS FR‐04041 ASK‐04052‐AC CDC‐02041‐MK1A CDC‐35052‐VPS FR‐04041‐CF ASK‐05041‐LM4 CDC‐04041‐HPK1A CDC‐35541‐VPS FR‐05041 ASK‐05052‐SFL CDC‐04052‐HPK1A CDC‐35552‐VPS FR‐05041‐CF ASK‐05541‐MS2 CDC‐05041‐HPK1A EU‐04041‐HP FR‐05541‐CF ASK‐05541‐MS3 CDC‐05052‐HPK1A EU‐04041‐HPMSB PI‐01451‐LS ASK‐15552‐LM2 CDC‐05541‐HPK1A EU‐04052‐HPMSB PI‐01451‐LS5 ASK‐15552‐MS3 CDC‐05542‐PK1A EU‐05041‐HPMSB PK‐01451‐WS ASK‐35041‐JHVA CDC‐05552‐HPK1A EU‐05052‐HPMSB PK‐01451‐WSSP CA‐05041‐HP CDC‐15552‐HPK1A EU‐05541‐HP UK‐05041‐HPMIN CA‐05041‐HPX CDC‐34041‐VPS EU‐05541‐HPMSB
  • Manufacturer
    Arrow International Inc.

Manufacturer

Arrow International Inc.