Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16635
Brand Name:Convatec Flexi-Seal Control Faecal Management System
Model:Product Code: 411107
Affected:All lots
Software version:
Recalling Organisation:Convatec (New Zealand) Ltd
WHK Gosling Chapman
Level 6, 51-53 Shortland Street
Auckland
Contact Information:0800 441 763
Manufacturer:Convatec Ltd
Issue:The manufacturer advises that the Auto-Valve™ has not been consistently performing relative to the inflation and deflation of the device's retention balloon.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Retail
Date Commenced:20/5/2014
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