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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00245-1
Product Name/Description T34L and NIKI T34 Ambulatory syringe pumps

Caesarea Medical Electronics T34L Syringe Pumps
Catalogue numbers: CE-100-104PSLNZ, CE-100-105PSLNZ, CE-100-106PSLNZ, CE-100-108PSLNZ,
CE-100-109PSLAU
All Pumps and Pump Housings manufactured from 2013 onwards

Caesarea Medical Electronics NIKI T34 Syringe Pumps
Catalogue numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS
All Pumps and Pump Housings manufactured from 2013 onwards

ARTG Number: 131232
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/03/2016
Responsible Entity REM Systems Pty Ltd
Reason/Issue Caesarea Medical Electronics (CME) has received reports of syringe pumps NIKI T34/T34L stopping and activating an alarm condition when being used in direct sunlight. If the user ignores or misinterprets the warnings on the pump display and restarts the pump, this may lead to an over infusion above the expected rate of delivery for the pump, which may result in adverse health consequences for the patient.
Recall Action Recall for Product Correction
Recall Action Instructions The manufacturer - CME recommends customers avoid using the pump in sunlight or, if it is necessary for the patient to go outdoors, protect the pump from exposure (for example by placing it in a pouch or a bag). The manufacturer is working on a permanent solution.

This action has been closed out on 05/04/2022
Contact Information 1800 737 222 - REM Systems