Z-0843-2021 Class II Ongoing
FDA device recall Z-0843-2021 was initiated by Medtronic Inc. on November 12, 2020 and is designated Class II. Reason for recall: 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 surr… The recall status is ongoing. Affected quantity: 46,461 affected systems.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- November 12, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,461 affected systems
Product Description
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide O.U.S. Worldwide Refer to Associated Documents and uploaded Consignee Lists/Spreadsheets. -Australia New Zealand -Canada -EMEA -Greater China -India -Japan -Latin America -South Korea -Southeast Asia -US
Code Information
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