Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1613-2021 — Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons

U.S. FDA — Device Enforcement · United States · 2021-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1613-2021
Date of alert: 2021-02-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00763000243357

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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