Events

Recall of BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, central venous Description:Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nitinol GW PG

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-01597-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01597-1
  • 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
    Navilyst medical, inc., the manufacturer of the bioflo picc with pasv valve technology, is conducting a recall based on information received from greatbatch medical, who manufacturers the viapeel ptfe peelable introducer. navilyst medical has confirmed that the affected sheaths from a greatbatch medical recall of the peelable introducers (greatbatch model number 10890-006) have been included in packaged bioflo picc kits. these particular introducers have the potential for the handles to detach from the sheath during use. this may result in user dissatisfaction and/or prolonged procedure, or if both handles detach, the sheath tube could migrate into the patient leading to an unplanned surgical retrieval.. navilyst medical has received several complaints from users, but to date, there have been no reports of patient injuries as a result of this issue.
  • Action
    Emergo is advising users to immediately stop using and quarantine the affected lot of Bioflo PICC Kits. Affected product is to be returned to the distributor Florey Medical Pty Ltd. Replacement product or credit will be issued via the distributor.

Device

BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, c...
  • Model / Serial
    BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, central venousDescription:Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nitinol GW PGItem Number: H965458830Catalogue Reference: 45-883Lot Number: 4908978Expiry: 30 June 2017 ARTG Number: 203831
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia