Stryker Heated Tube Set with Real-Time Pressure Sensing recall
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable…
Why was Stryker Heated Tube Set with Real-Time Pressure Sensing recalled?
The heated tube sets were consistently leaking and detaching from the cassette.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable…
- Recalling firm
- Stryker Corporation
- Quantity
- 19,083 boxes
- 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.
- Recall date
- June 12, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)