Medtronic recalls Guardian Sensor (3) devices for potential inaccurate glucose readings when used with hydroxyurea. Affected units have specific packaging codes. Contact Medtronic for details.
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 Guardian Sensor (3) glucose monitors because they may give inaccurate high readings when used with hydroxyurea, an anti-cancer drug. This could lead to incorrect diabetes management decisions.
The sensor may show falsely high glucose levels when used with hydroxyurea. This could cause unnecessary insulin doses or delayed treatment adjustments, risking health complications.
People using Medtronic Guardian Sensor (3) devices with hydroxyurea treatment for cancer. Those with diabetes who take hydroxyurea are most at risk.
Check for packaging with GTIN: 00763000140779 or 00763000337049. The product is sold in 1-packs for continuous glucose monitoring.
Look for GTIN codes 00763000140779 or 00763000337049 on the packaging.
Reach out to Medtronic for specific guidance on handling the device.
The Guardian Sensor (3) may show inaccurate high glucose readings when used with hydroxyurea, an anti-cancer drug.
Check the packaging for the GTIN codes and contact Medtronic for specific instructions.
The recall is for potential inaccurate readings, not direct injury. However, incorrect glucose levels could lead to health issues.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1602-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1602-2021 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.