FDAFebruary 26, 2021device

Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously mon...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic

UPCs

006431697040840076300024333300763000318857

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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