MHRA Issues Alert on Clinical Innovations’ Vacuum Delivery System
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert for Clinical Innovations’ Kiwi Complete Vacuum Delivery System, a device that assists women giving birth vaginally.
The agency directed users to quarantine all devices bearing the lot number 181144, as they fail to achieve or maintain vacuum during use.
MHRA said the failure can happen due to insufficient solvent being applied during the manufacturing process. The agency urged users to contact the UK supplier to arrange for return and replacement.