Z-1282-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- July 4, 2018
- Termination Date
- June 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approximately 9,328 registered users
Product Description
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Reason for Recall
The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
Distribution Pattern
Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa.
Code Information
UDI - (01)00643169693142(10)