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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 072 07 13 000
Date submitted: 7/9/2013
Manufacturer:Medtronic Diabetes
Device Type:Insulin Infusion Pump, Paradigm
Description:Insulin Infusion Pump
Medical Device Identifier:Model : ( MMT-326A, MMT-332A );
Lots : (H8416432, H8420977, H8422490, H8424676, H8437486, H8441420 ,See attached for full list )
Reason of Field Safety Corrective Action:potential that reservoirs from these lots are at increased risk for leaking
Remedy Action:1)If you only have reservoirs with a lot number listed in the attachment, do not use these reservoirs. Medtronic recommend that you switch to your back-up insulin injection plan according to the direction of your health care provider until you receive new reservoirs. Medtronic would like to emphasize the importance of testing your blood glucose levels at least four times per day as stated in the recommendation of the pump user guide.
2) If you do have reservoirs with a lot number not listed in the attachment, then you should only use these reservoirs because these are not affected by this recall.

3)Any unused reservoirs included in this recall should be returned to your supplier.

4)Please note that Medtronic will replace all reservoirs from the affected lots.
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (011) 2628939
Report Source:NCMDR
Source Ref. Number:C4E7E952F03D6
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf