Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, posted a medical device safety alert concerning CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL [Product code: 2C1079K. Lot number: 13M061. Expiry date: 30 Nov 2016] manufactured by Baxter Healthcare.
The manufacturer received complaints that reported leak in the reservoir. This issue is being investigated and only affects the 0.5 mL PCM Watch.
The leak in the reservoir may lead to medication contamination, which could result in infection or other serious adverse health consequences. Product recall is on-going.
According to the local supplier, the affected lot is not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 May 2015