Recall Z-2260-2015— Medtronic MiniMed Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic MiniMed Inc., initiated 2015-06-19, terminated 2015-10-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- Medtronic MiniMed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-19
- Terminated
- 2015-10-02
- Firm location
- Northridge, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.