Z-1728-2019 Class II Terminated
FDA device recall Z-1728-2019 was initiated by Stryker Corporation on March 7, 2019 and is designated Class II. Reason for recall: The heated tube sets were consistently leaking and detaching from the cassette. The recall status is terminated (terminated March 8, 2024). Affected quantity: 19,083 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- March 7, 2019
- Termination Date
- March 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,083 boxes
Product Description
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.
Reason for Recall
The heated tube sets were consistently leaking and detaching from the cassette.
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.
Code Information
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, 56006008, 56006014, 56006146, 56006148, 56006150, 56006163, 56006185, 56006187, 56006189, 56006210, 56006218, 56006220, 56006242, 56006255, 56006259, 56006261, 56006263, 56006282, 56006284, 56006286, 56006301, 56006303, 56006305, 56006307, 56006317, 56006342, 56006344, 56006376, 56006407, 56006424, 56006426, 56006442, 56006450, 56006463, 56006523, 56006525, 56006574, 56006576, 56006578, 56006601, 56006609, 56006620, 56006622, 56006631, 56006641, 56006643.