Events

Avis De Sécurité sur Arrow® Pressure Injectable Peripherally Inserted Central Catheter (PICC) – 4FR

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
    2015-09-28
  • 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 international, inc. (“arrow”) is notifying its customers that received the products referenced above; there is a labelling inaccuracy in the instructions for use (ifu) and patient card. the ifu and patient card contained within the these products state the picc can withstand up to ten (10) pressure injections, however, the picc has only been tested to withstand five (5) pressure injections. .

Device

Arrow® Pressure Injectable Peripherally Inserted Central Catheter (PICC) – 4FR
  • Modèle / numéro de série
    ASK-05041-CHC2 EU-04041-HP EU-25041-IR PR-05041-HP ASK-05041-LM4 EU-04041-HPMSB EU-25541-HP PR-05041-HPX ASK-05041-QV EU-05041-HPMSB EU-25541-HPMSB PR-05541-HPX ASK-05541-MS3 EU-05541-HP EU-25541-IR UK-04041-RDE1 CA-05041-HP EU-05541-HPMSB FR-04041 UK-04041-THT CA-05041-HPX EU-24041-HP FR-04041-CF UK-05041-HPMIN CDC-04041-HPK1A EU-24041-HPMSB FR-05041 UK-05041-MSB CDC-05041-HPK1A EU-24041-IR FR-05041-CF UK-05041-RDE1 CDC-05541-HPK1A EU-25041-HP FR-05541-CF UK-05041-THT
  • Manufacturer
    Arrow International Inc.

Manufacturer

Arrow International Inc.