Recall of PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” catheter)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Allegra Orthopaedics Limited.

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-2016-RN-00493-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-21
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    Allegra orthopaedics is performing a recall of specific lot numbers of the pf6 tube assembly which is a component of the peripheral vascular infusion/aspiration catheter or “pad” catheter. this is the only component of the pad affected by this recall action as this is the component that is ethylene oxide sterilised.Following a review of the validation of the ethylene oxide sterilisation process for the pf6 tube assembly, it was apparent that there is insufficient evidence to demonstrate that a sterility assurance level (sal) of at least 10-6 was achieved.
  • Action
    Allegra Orthopaedics is advising users to inspect stock and quarantine any remaining units of the affected devices for return.

Device

  • Model / Serial
    PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” catheter)Catalogue Number: 20-000965Lot Number: 15012700Expiry Date: April 2017ARTG Number: 164450
  • Manufacturer

Manufacturer