Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Reason: The heated tube sets were consistently leaking and detaching from the cassette.

Code information: UDI - 07613327055641; Lot numbers: 18G0273, 18H0323, 18H0354, 56004327, 56004391, 56004434, 56004478, 56004526, 56004592, 56004665, 56004667, 56004706, 56004708, 56004784, 56004832, 56005325, 56005376, 56005378, 56005380, 56005411, 56005450, 56005459, 56005538, 56005540, 56005633, 56005635, 56005744, 56005790, 56005899, 56005901, 56005989, 56005997, 56005999, 56006142, 56006154, 56006270, 56006340, 56006434, 56006521, 56006527, 56006556, 56006560, 56006606.

Distribution pattern: Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.