The FDA has designated Tytek Medical’s recall of hundreds of TM-317 PneumoDart pneumothorax needles as a Class I recall.
The recall began in November 2019, spanning 920 devices. The needles have a risk of blockage that could delay treatment due to adhesive that formed during the manufacturing process, the agency said.
The needles are used in life-threatening situations to let out air that has become trapped in a patient’s pleural cavity, which can be caused by lung trauma or a collapsed lung. The affected devices could cause further injury, the FDA said.