FDAClass IIMay 26, 2021

Medtronic recall

Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for…

Why was Medtronic recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lot numbers within active shelf life

Product
Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for…
Recalling firm
Medtronic Inc.
Quantity
207 units
Distribution
Worldwide distribution.
Recall date
May 26, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls