Events

Recall of ARROW PICC Kits with Peel-Away Sheath Component

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00408-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00408-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Arrow international has received complaints related to peel away sheath flare for the arrow picc kits. the instructions for use included with the kits do not inform the user that a skin nick or alternate enlargement method may be required for difficult insertions. the use of a skin nick reduces the possibility of sheath flare and subsequent complications. there is a remote possibility the device may cause a delay in treatment or minor damage to the vessel wall or subcutaneous tissue.
  • Action
    Teleflex is advising users that they may be required to use an alternate enlargement method or perform a skin nick for difficult insertions. Customers are also requested to include the supplementary card (Product Notice) with their affected stock.

Device

ARROW PICC Kits with Peel-Away Sheath Component
  • Model / Serial
    ARROW PICC Kits with Peel-Away Sheath ComponentCatalogue Numbers: PI-01351-LS, PI-01351-SS, PI-01451-LS, PI-01451-SS, PI-01552-LS, PI-01552-SS, PR-05041, PR-05041-T, PR-05042, PR-05052, PR-05052-MWMultiple Lot NumbersARTG Numbers: 148783 and 148784
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd