FDA recall Z-1600-2021

Product

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

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-02-26

Report date

2021-05-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northridge, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1600-2021