Recall Z-1604-2021— Medtronic Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., initiated 2021-02-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.. Reason: Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-02-26
- Firm location
- Northridge, CA, United States
Product description
Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Reason for recall
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Data sourced from openFDA. This site is unofficial and independent of the FDA.