Medtronic Inc. recalls CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, th…

Recall date

August 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2898-2016

FDA classification

Class II

Brand / firm

Medtronic Inc.

Sold / distributed

Nationwide Distribution to TN, MN, and WA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.