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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00690-1
Product Name/Description Medtronic MiniMed Insulin Reservoirs

Model Numbers: MMT-326A and MMT-332A

Batch Numbers: H8442973, H8463297, H8467888, H8469703, H8473271, H8478398, H8492449, H8494645, H8496561, H8510440, H8512826, H8517079, H8539013 and H8627745

ARTG Number: 169959
Recall Action Level Consumer
Recall Action Classification Class I
Recall Action Commencement Date 5/07/2013
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue There is the potential that reservoirs from the affected batches may have an increased risk of leaking. A leak in the reservoir may result in delivery of less insulin than needed. In addition, if the user has a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify them.
Recall Action Recall
Recall Action Instructions Medtronic Diabetes is requesting customers to not use reservoirs from the affected batch. If no alternative product is available, customers are requested to switch to their back-up insulin injection plan. Replacement of affected batches can be arranged by contacting the Medtronic 24 Hour Help Line. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-minimed-130716.htm .
Contact Information 1800 777 808 (option 1) - Medtronic 24 Hour Helpline