medical Class II Updated 2021-05-26

Medtronic Inc. recalls Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the fol

Recalled Product

Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - 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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