UK MHRA has issued a Medical Device Alert (MDA) on Crystal Metal Disposable Laryngoscopes manufactured by Penlon Medical Ltd. Mac 3 blades have been incorrectly packaged and labelled as Mac 4 blades. All devices labelled as size Mac 4 with expiry dates up to and including August 2016 are potentially affected.
Penlon issued an updated Field Safety Notice (FSN) on 14 October 2011, which contains corrected expiry dates for the affected blades. Penlon has not had sufficient confirmation from users that they have received and acted on the updated FSN, resulting in this MDA.
The MDA is directed at all Operating Theatre staff, Anaesthetists, Intensive Care Staff, ENT staff, A&E departments and Stores personnel, with Corrective Actions due to be complete by November 16th.
This post is an excerpt from the full MDA, which should be consulted and can be found here.