MHRA Issues Device Alert for Covidien’s Pleuraseal System
February 15, 2011
The UK’s Medicines and Healthcare products Regulatory Agency has issued a device alert for Covidien’s Lung System Sealant, Pleuraseal, in support of a company-issued recall. The MHRA issued the alert because Covidien has been unable to confirm whether or not its customers have received the Field Safety Notice associated with the device. The devices suffer from persistent air leaks following pulmonary resection surgery.