FDA Device recall Z-2776-2015
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer by Edward Lifesciences, citing 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 sy….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2776-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-31 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edward Lifesciences |
| Distribution | US |
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.
Identifiers
| code_info | Model # Lot # Expiration Date PX2X3 59987950 3/12/2017 PX2X3 60008882 3/24/2017 PX2X3 60043561 5/1/2…Model # Lot # Expiration Date PX2X3 59987950 3/12/2017 PX2X3 60008882 3/24/2017 PX2X3 60043561 5/1/2017 PX3X3272 59994227 3/8/2017 PX3X3272 60025936 4/15/2017 PX3X3AN 60030889 4/17/2017 PX3X3AN 60008883 3/26/2017 PXAK2066 60025499 2/27/2017 PXAVMP3 60036757 4/27/2017 PXMK1970 60001398 4/16/2017 PXMK2043 59994210 3/9/2017 PXMK2043 60001412 3/17/2017 PXMK2043 60020166 4/5/2017 PXMK2043 60030868 4/26/2017 PXMK2144 60019038 4/17/2017 PXMK2217 59994267 3/12/2017 PXMK2217 60030969 4/20/2017 PXMK2217 60020235 4/15/2017 PXVK0458 59983333 4/6/2017 PXVK1079 59994195 3/11/2017 PXVK1079 60020153 3/31/2017 PXVMP2X31 59998630 3/12/2017 PXVMP2X31 59999004 3/13/2017 PXVMP2X31 59999006 3/13/2017 PXVMP3X31 59994223 3/13/2017 PXVMP3X31 60049581 4/23/2017 PXVMP3X32 60025874 3/31/2017 T001746A 60036771 4/30/2017 T001759A 59976102 3/10/2017 T001759A 60014134 3/31/2017 T001759A 60020177 4/13/2017 T001759A 60049570 5/4/2017 T330V11A 60014160 3/29/2017 T333F00A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2776-2015%22
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