Reported Jan 20, 2021 · Ongoing
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software…
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?
- CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool
- for Diabetes Software Uploader versions3.1.5.000 3.1.2.000
- Lot codes and dates
- CareLinkTM Personal (MMT-7333) using CareLink
- Uploader (ACC-7350) UDI (GTIN/UPN)00763000424121 CareLinkTM system (MMT-7350) using CareLink
- Uploader (ACC-7350) UDI (GTIN/UPN)00763000424138
- Amount recalled
- 46,461 affected systems
Where it was sold
- Nationwide
Why it was recalled
Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.
This product could cause temporary or reversible health problems — stop using it.
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