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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00681-1
Product Name/Description T34 Ambulatory Syringe Pumps

Catalogue Numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS

All Pump Serial Numbers

ARTG Number; 131232
(REM Systems - Infusion pump, syringe)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/06/2018
Responsible Entity REM Systems Pty Ltd
Reason/Issue It has been identified that there can be a 2mm +/- overall length difference between various manufacturers PP3 batteries that could be used in NIKI T34 Ambulatory Syringe Pumps.
This could result in movement within the battery housing leading to a possible loss of connection, resulting in the pump powering down and a possible under infusion of pain medication occurring.
Recall Action Product Defect Correction
Recall Action Instructions If a battery within the NIKI T34 housing appears loose, careful adjustment of the battery connections may be required as detailed in the Customer letter

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