Reported May 26, 2021 · Ongoing
Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN:…
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- Medtronic
- REFMMT-7008A, Enlite Glucose
- Sensor for the following packagingENLITE
- PLUS 5PK 23L 1CL /GTIN20643169541706
- ENLT PLUS 5PK 2L 1CL PR/ GTIN20643169786725
- ENLITE PLUS 5PK 23L 1CL/ GTIN20763000421292 -
- Product Usageintended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes
- Lot codes and dates
- All Lot numbers within active shelf life
- Amount recalled
- 213,110 units
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Why it was recalled
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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