Medical device manufacturer, Novadaq Technologies Inc., has issued a medical device safety alert concerning its SPY-PHI Drape. The affected model numbers are HH2000 and HH2020.
According to the manufacturer, a pinhole through the drape material was identified following use of a drape in a surgical procedure. While there have been no reports of infection submitted to the manufacturer as a result of the drape material integrity being compromised, a remote possibility exists that a compromised drape may cause harm to a patient through infection.
Product recall is on-going.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 June 2017