Events

Recall of 70mL Centrifuge Bowl

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Haemonetics 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-01006-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01006-1
  • 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
    Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. a leaking bowl may potentially expose the operator to blood. in addition, because some amount of autologous blood intended to be returned to the patient would not be available for return, an allogenic blood transfusion may be required.
  • Action
    Haemonetics is requesting customers: 1. Discontinue use of the affected products; and 2. Return any unused product to Haemonetics Contact your local customer service representative to coordinate the return, shipment and credit receipt of unused product.

Device

70mL Centrifuge Bowl
  • Model / Serial
    70mL Centrifuge BowlCell Saver 5/5+ Bowl Set - 70mLProduct ID: 0291E-00Cell Saver Elite Processing Set - 70mLProduct ID: CSE-P-70Cell saver 5/5+ Bowl Set - 70mLProduct ID: 0291A-00ARTG Number: 123999
  • Manufacturer
    Haemonetics Australia Pty Ltd

Manufacturer

Haemonetics Australia Pty Ltd