Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:18718
Brand Name:Sorin Heater Cooler Systems 1T and 3T devices
Model:
Affected:All serial numbers starting with 16SXxxxx are affected
Software version:
Recalling Organisation:Obex Medical Ltd
Level 3, 109 Carlton Gore Road
Newmarket
Auckland 1023
Contact Information:0800 656 539
Manufacturer:Sorin Group Deutschland GmbH
Issue:Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to the Instructions for Use. Without vigilant performance of the disinfection and maintenance procedures per the Instructions for Use, organisms can multiply in a heater cooler device and potentially form biofilm.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:23/6/2015
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