Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Check against the official notice below — it lists the full affected range.
Stryker Corporation has recalled 19,083 boxes of Stryker Heated Tube Set with Real-Time Pressure Sensing (Model REF 0620-040-690), which is an accessory to the PNEUMO SURE High Flow Insufflator. The heated tube sets were found to be consistently leaking and detaching from the cassette. The affected products were distributed nationwide to medical facilities, including government and military facilities, as well as internationally to Argentina, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Saudi Arabia, UAE, and Uruguay.
The recalled products can be identified by UDI 07613327055658 and include numerous lot numbers ranging from 56004333 through 56006. The record does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The heated tube sets were consistently leaking and detaching from the cassette.
Reason for recall: The heated tube sets were consistently leaking and detaching from the cassette. Distribution: 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. Quantity: 19,083 boxes Lot/code info: UDI - 07613327055658; Lot numbers: 56004333, 56004335, 56004337, 56004342, 56004352, 56004375, 56004393, 56004419, 56004421, 56004423, 56004435, 56004445, 56004447, 56004465, 56004481, 56004485, 56004512, 56004520, 56004534, 56004541, 56004575, 56004577, 56004586, 56004597, 56004602, 56004626, 56004630, 56004643, 56004645, 56004649, 56004651, 56004710, 56004723, 56004725, 56004741, 56004752, 56004754, 56004757, 56004782, 56004786, 56004793, 56004836, 56004838, 56004840, 56004850, 56004863, 56004884, 56005075, 56005077, 56005081, 56005083, 56005085, 56005087, 56005089, 56005091, 56005093, 56005110, 56005112, 56005114, 56005116, 56005117, 56005124, 56005126, 56005141, 56005143, 56005145, 56005147, 56005149, 56005164, 56005168, 56005171, 56005173, 56005175, 56005177, 56005186, 56005190, 56005192, 56005194, 56005218, 56005223, 56005230, 56005236, 56005247, 56005253, 56005269, 56005275, 56005292, 56005292, 56005299, 56005310, 56005349, 56005355, 56005362, 56005364, 56005366, 56005368, 56005382, 56005384, 56005397, 56005409, 56005415, 56005417, 56005419, 56005431, 56005433, 56005435, 56005448, 56005463, 56005465, 56005500, 56005502, 56005511, 56005517, 56005519, 56005521, 56005525, 56005550, 56005552, 56005576, 56005578, 56005580, 56005582, 56005619, 56005644, 56005665, 56005680, 56005682, 56005726, 56005738, 56005759, 56005799, 56005808, 56005829, 56005854, 56005856, 56005887, 56005890, 56005909, 56005911, 56005919, 56005929, 56005937, 56005952, 56005970, 56005995, 56006006, 56006
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.