Z-2106-2020 Class II Ongoing

Recalled by Medtronic Inc. — Northridge, CA

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.