www.med-art.com
Reuters (8/16) reports Covidien Plc announced
a recall Wednesday for some lots of its re-usable, cuffed Shiley tracheostomy
tubes, a ventilation device that provides an opening for removing tracheal and
lung fluids during surgery. Based on leakage complaints it received, the FDA designated it a Class I recall, which means
that problems with device could lead to serious health complications or death.
According to Coviden spokesperson Rhonda Luniak, the recall includes roughly
330,000 Shiley tubes from the size 8 adult lots that the company manufactured
from October 2009 through June 2012.
Fierce Medical Devices (8/16, Hollmer) also
covers the story and notes that is Covidien's second recall "in the past
few months, as the company discovered a packaging issue in some of its
Roticulator staplers back in May, recalling 5 models over sterility worries";
and in July, Covidien "warned UK regulators that the batteries in some of
its at-home ventilators could fail, but the company did not issue a recall of
the devices."
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