Events

Avis De Sécurité sur ARROW® PICC

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Arrow International Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2015-07-31
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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.