Events

Recall of Arrow Internatinal PICC Kts with Peel-Away Sheath Component

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Arrow International Inc.

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
    18967
  • Event Initiated Date
    2015-08-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Reason
    The manufacturer is recalling certain lots of products due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. although the issue does not pose a significant risk to the patient, it may cause a delay in treatment when placing the catheter.
  • Action
    Product to be returned to supplier

Device

Arrow Internatinal PICC Kts with Peel-Away Sheath Component
  • Model / Serial
    Model: AH-CA-05041-HP, AH-CA-05052-HP, AH-PI-01451-LS, AH-PK-01451-WS, Affected: 23F14B0844, 23F14L0810, 23F14K1361, 23F14M0484, 23F14J1048, 23FJ0076, 23F15D0882, 23F150193, 23F14J0437, 23F14B0935, 23F14H1535. 23F15A0278, 23F15D0907, 23F14D0042 and 23F15D0284.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc