PlainRecalls
FDA Devices Moderate Class II Terminated

CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

Reported: October 5, 2016 Initiated: August 5, 2016 #Z-2898-2016

Product Description

CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

Reason for Recall

Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

Details

Recalling Firm
Medtronic Inc.
Units Affected
33 units
Distribution
Nationwide Distribution to TN, MN, and WA
Location
Northridge, CA

Frequently Asked Questions

What product was recalled?
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.. Recalled by Medtronic Inc.. Units affected: 33 units.
Why was this product recalled?
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2898-2016.