medical Class II Updated 2021-05-26

Medtronic Inc. recalls Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the foll

Recalled Product

Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.


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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