Events

Field Safety Notices about ARROW® PICC

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
    2015-07-31
  • Event Country
    Slovenia
  • 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 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
  • Model / 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.