Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19026
Brand Name:Edwards Lifesciences Pressure Monitoring Kit and Set
Model:PXMK2043 & PXMK2217
Affected:PXMK2043, Lot numbers 59994210, 60001412, 60020166 & 60030868 and PXMK2217 Lot numbers 59994267, 60020235 & 60030969
Software version:
Recalling Organisation:Edwards Lifesciences (New Zealand) Limited
171 Morrin Road
St John
Auckland 1072
Contact Information:021 313 234
Manufacturer:Edwards Lifesciences LLC
Issue:Edwards Lifesciences is recalling specfic lots of product due to a flow restriction issue 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.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:28/8/2015
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