February 27, 2020
FDA: Class I recall of Tytek Medical TM-317 PneumoDart-Pneumothorax Needle
Editor's Note
The Food & Drug Administration on February 25 identified the recall of Tytek Medical’s TM-317 PneumoDart-Pneumothorax Needle as Class I, the most serious.
The recall was initiated because of the risk of blockage in the needles caused by the presence of adhesive from the assembly process.
The company has received one complaint, and there have been no reported injuries or deaths.
Manufacturing and distribution dates were June 3, 2019 to September 17, 2019.
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