Regulator issues urgent warning over defective hearing aid batteries
People who have bought ZeniPower mercury-free hearing aid batteries to check the best before date on the packs due to two defective batches.
The Medicines and Healthcare products Regulatory Agency (MHRA) is asking people who have bought ZeniPower mercury-free hearing aid batteries to check the best before date on the packs.
Due to a manufacturing fault, there is a low risk of the batteries exploding during use or if depleted.
This is a precautionary measure as no adverse incidents that resulted in an injury have been reported to MHRA through our safety monitoring system, the Yellow Card Scheme.
The affected batteries have best before dates of 08.2018 and 09.2018. All other batches ZeniPower mercury-free hearing aid batteries are not affected. If in doubt, do not use the batteries.
Pharmacists or retailers which have affected stock on their shelves should remove them immediately and return any remaining stock to their original supplier.
John Wilkinson, MHRA’s Director of Medical Devices said:
While the risk is very low, it is important people check if their hearing aid batteries are affected and if they are in doubt do not use the battery.
Patient safety is of paramount importance and continually monitored. Our priority is to ensure appropriate action is taken to ensure public safety.
We continue to encourage people to report any issues involving medical devices to the MHRA via our Yellow Card Scheme.
- MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health.
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Published: 10 March 2016