18 Aug 2012
MEDICAL DEVICE ALERT — Action by 31 August 2012
Ref: MDA/2012/057
Date 17/08/12
Sterile Water for Irrigation 1000ml
(manufactured by Baxter Healthcare Ltd)
Lot number 12D10B26
Product code UKF7114
The Medicines and Healthcare products Regulatory Agency has issued a medical device alert for Sterile Water for Irrigation manufactured by Baxter Healthcare. Baxter Healthcare supplied the lot from 1st May 2012 to 22nd May 2012 inclusive.
The alert has been issued because some bottles within the affected batch have been found to be contaminated with Aspergillus. The affected bottles were found in France. The MHRA is currently investigating this problem and independent testing of the affected batch is being carried out.
As a precautionary measure, bottles in the affected batch should be identified and quarantined by 31 August 2012. Baxter Healthcare should be contacted for information regarding stock availability and further updates (Tel: 01635 206345 or Email: surecall@baxter.com).
