Alerta De Seguridad para Single Use Home Ventilation Breathing Circuit

Safety alert

2017-10-27

2017-10-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20171027b.html

Medical device safety alert: fisher & paykel healthcare single use home ventilation breathing circuit the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has posted a medical device safety alert concerning single use home ventilation breathing circuit, manufactured by fisher & paykel healthcare. [reference number: rt443; lot numbers: from lot 2100089390 to lot 2100233760] the manufacturer is initiating a voluntary recall of the products due to an increased rate of split tubing cuffs in catheter mounts manufactured on specific dates. a split tubing cuff on the catheter mount may potentially cause a leak, which could lead to patient hypoxaemia if undetected. users are advised to take the following actions: identify any affected products in their inventory by checking the ref and lot number on the packaging. for the affected products, disconnect the catheter mount component, cut this in half and then dispose the entire kit. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-16-to-20-october-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 october 2017.