UK medical device regulators have issued a warning to healthcare providers after a chest drain unit was found to be faulty.
The Pleuraseal III chest drainage bottle manufactured by Rocket Medical has been found to have a faulty seal and there are fears the tubing could become occluded, possibly leading to patients suffering a collapsed lung.
The Medical Device Alert from the Medicines and Healthcare products Regulatory Agency (MHRA) covers units with the product codes R54543 and R54545 only.
All affected devices are now being recalled.
The warning states: “The manufacturer published a Field Safety Notice in September 2012 to notify users and prompt them to take action. The manufacturer has not received sufficient confirmation that this has been received and acted upon.”
To read the warning, click here.
