Z-2106-2020 Class II Ongoing
FDA device recall Z-2106-2020 was initiated by Medtronic Inc. on May 20, 2019 and is designated Class II. Reason for recall: Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitt… The recall status is ongoing. Affected quantity: 23,978.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- May 20, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,978
Product Description
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Reason for Recall
Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.
Distribution Pattern
US Nationwide distribution.
Code Information
Model Number CSS7200 (Guardian Connect App: iOS); Catalog Numbers: MMT-7821 (Guardian Connect Transmitter - GST4C); UPN - 00763000186333. There are no assigned lot or serial numbers.