Company: Medtronic Inc.
Date of Enforcement Report 10/5/2016
Class lI:

PRODUCT

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.
Recall Number Z-2898-2016

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

RECALLING FIRM/MANUFACTURER
Medtronic Inc., Northridge, CA on 9/27/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33 units

DISTRIBUTION
TN, MN, and WA

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