The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a Medical Device Alert concerning sterile water for irrigation 1000ml manufactured by Baxter Healthcare Ltd. The affected product code is UKF7114, lot no 12D10B26. This lot was supplied by Baxter from 1 May 2012 to 22 May 2012 inclusive.
There is a risk of contamination of this batch as there has been a report in France that bottles within this batch were contaminated with Aspergillus. This case is still under investigation and the affected batch is being independently tested. Meanwhile, customers are advised to quarantine bottles in the affected batch and liaise with Baxter regarding availability of supplies and for updates.
The MHRA is liaising with Baxter and will provide further updates as necessary.
For details, please refer to the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/index.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 20 August 2012