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Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: All ZeniPower Mercury-free Hearing Aid Batteries

11 Mar 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has issued an alert concerning all ZeniPower mercury-free hearing aid batteries manufactured by ZeniPower Battery Company Limited. The affected product code numbers are as follows:

  • A675P MF – R44 zinc air size 675 for cochlear implants
  • A675 MF – R44 zinc air size 675
  • A13 MF – R48 zinc air size 13
  • A312 MF – R41 zinc air size 312
  • A10 MF – R70 zinc air size 10

[Only batteries with best before dates of '08-2018' and '09-2018' are affected]

According to the MHRA, the problem is caused by excessive gassing, as the zinc electrode reacts with the electrolyte to generate hydrogen. The battery may expand and possibly explode on rare occasions.

For details, please refer to the MHRA website: https://www.gov.uk/drug-device-alerts/all-zenipower-mercury-free-hearing-aid-batteries-low-risk-of-batteries-exploding-during-use-or-if-depleted

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 11 March 2016

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