Field Safety Notices about Arrow® Pressure Injectable Peripherally Inserted Central Catheter (PICC) – 4FR

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Arrow International Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-09-28
  • Event Country
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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

  • Model / Serial
    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

Manufacturer