Recall Z-2776-2015— Edward Lifesciences, Llc
Class II · Terminated
Class II FDA medical device recall by Edward Lifesciences, Llc, initiated 2015-07-31, terminated 2016-07-08. It names one FDA 510(k) clearance: K142749. Product: 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.. Reason: 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..
- Recalling firm
- Edward Lifesciences, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-31
- Terminated
- 2016-07-08
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.