Z-1600-2021 Class II Ongoing
FDA device recall Z-1600-2021 was initiated by Medtronic Inc. on February 26, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 20,913 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 26, 2021
- Initiation Date
- February 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,913 units
Product Description
Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 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.
Distribution Pattern
Worldwide distribution.
Code Information
All Lot numbers within active shelf life