Company: Medtronic MiniMed Inc..
Date of Enforcement Report 8/5/2015
Class lI:
PRODUCT
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712. Recall Number Z-2260-2015
REASON
Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed Inc., Northridge, CA on 6/19/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1936 units
DISTRIBUTION
Internationally
___________________________________
