PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 5, 2015 Initiated: June 19, 2015 #Z-2260-2015

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.

Details

Recalling Firm
Medtronic MiniMed Inc.
Units Affected
1936 units
Distribution
Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.
Location
Northridge, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Medtronic MiniMed Inc.. Units affected: 1936 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 5, 2015. Severity: Moderate. Recall number: Z-2260-2015.