www.fdanews.com/articles/172986-teleflex-recalls-hudson-sheridan-sher-l-bronch-endobronchial-tube
Teleflex Recalls Hudson Sheridan Sher-l-Bronch Endobronchial Tube
September 8, 2015
Teleflex is voluntary recalling 188,195 units of its Hudson Sheridan Sher-l-Bronch Endobronchial Tube. The Class I recall covers 233 lots across 12 product codes.
The recall comes after 78 customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube.
This may cause the device to leak, causing a risk of respiratory distress or hypoxia that can lead to the need to re-intubate the patient.
Teleflex issued an urgent medical device recall letter dated June 1, 2015, to domestic and foreign hospitals and distributors. — Michael Cipriano