FDAFebruary 26, 2021device

Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with...

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

0076300024335700763000318871

Recall history

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

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