Events

Recall of 0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare 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-2014-RN-01091-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01091-1
  • 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
    Investigation of a small number of customer complaints has confirmed a reported problem of solution leaking into the overpouch. it has been identified that the issue was caused by a component used in the manufacture of the lots above, and is confined to these batches. there are no other affected products. this issue potentially impacts the sterility of the irrigation fluid.
  • Action
    Customers are advised to locate and remove all of the affected products and lot numbers from their facility. The affected product should be returned for credit by contacting Baxter Healthcare Customer Service. Also, customers are advised to bring this matter to the attention of relevant prescribers within their hospital so that any patient who is undergoing infusion, or has very recently received an infusion of this product, can be monitored. This action has been closed-out on 22/08/2016.

Device

0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml
  • Model / Serial
    0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml0.9% Sodium Chloride for Irrigation 2000mlProduct Code: AHB7616Batch Numbers: S77N6 & S77R8 (Expiry Date: July 2016) and S78F1 (Expiry Date: Aug 2016)Water for Irrigation 2000mlProduct Code: AHB7606Batch Numbers: S77N5 (Expiry Date: July 2016) and S78A6 (Expiry Date: Aug 2016)ARTG Number: 155928
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd