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.
This recall has been terminated (originally issued March 7, 2019).
- Company
- Stryker Corporation
- Recall Initiated
- March 7, 2019
- Terminated
- March 8, 2024
- Recall Number
- Z-1728-2019
- Quantity
- 19,083 boxes
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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.
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, 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.
Root Cause
Under Investigation by firm
Action Taken
The recalling firm issued letters dated 3/7/2019 via certified mail on 3/7/2019. A second letter dated 3/7/2019 was issued on 4/15/2019 via certified mail to two customers which included an additional lot number for one of the products.