Reported Sep 23, 2015 · Terminated
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors…
Edward Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edward Lifesciences, Llc · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
- Lot codes and dates
- Model # Lot # Expiration Date
198 of 198 codes
PX2X3599879503/12/2017PX2X3600088823/24/2017PX2X3600435615/1/2017PX3X3272599942273/8/2017PX3X3272600259364/15/2017PX3X3AN600308894/17/2017PX3X3AN600088833/26/2017PXAK2066600254992/27/2017PXAVMP3600367574/27/2017PXMK1970600013984/16/2017PXMK2043599942103/9/2017PXMK2043600014123/17/2017PXMK2043600201664/5/2017PXMK2043600308684/26/2017PXMK2144600190384/17/2017PXMK2217599942673/12/2017PXMK2217600309694/20/2017PXMK2217600202354/15/2017PXVK0458599833334/6/2017PXVK1079599941953/11/2017
- Model # Lot # Expiration Date
- Amount recalled
- 13,077 (U.S.) and 12,306 (International)
Where it was sold
- Nationwide
Why it was recalled
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
This product could cause temporary or reversible health problems — stop using it.
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