Medtronic recalls Enlite Glucose Sensors for patients on hydroxyurea, which may cause inaccurate elevated glucose readings. Affected units have specific packaging codes.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Medtronic is recalling Enlite Glucose Sensors that may give inaccurate high glucose readings when used by patients taking hydroxyurea. This could lead to incorrect diabetes management decisions.
The sensor may show falsely high glucose levels when used with hydroxyurea. This could cause patients to make incorrect treatment decisions about their diabetes care.
Patients with diabetes using hydroxyurea medication are most at risk. The recall applies to specific packaging codes sold outside the US.
Check for packaging with GTIN: 20763000252032. The product is not distributed in the US and is intended for use with Medtronic Diabetes glucose monitoring systems.
Look for the GTIN code 20763000252032 on the packaging.
The sensor may give inaccurate elevated glucose readings when used with hydroxyurea, an anti-neoplastic drug.
No, the product is not distributed within the US.
The recall record does not specify a remedy, so no action is required beyond checking the packaging.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1617-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1617-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
