medical Class II Updated 2021-05-26

Medtronic Inc. recalls Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the follo

Recalled Product

Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.


Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: All Lot numbers within active shelf life
View official government recall

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