Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:14460
Brand Name:Biosense Webster SmartAblate Irrigation Tubing Set
Model:Product Code: SAT001
Affected:Lot: ACA43707
Software version:
Recalling Organisation:Johnson & Johnson (New Zealand) Limited
507 Mt Wellington Highway
Mt Wellington
AUCKLAND 1060
Contact Information:0800 922 638
Manufacturer:Biosense Webster Inc
Issue:The manufacturer has identifed that some lots of these devices have been incorrectly assembled with the arrows on the tubing pointing towards the drip chamber instead of towards the stop cock.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:8/4/2013
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