Z-2980-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- July 15, 2020
- Termination Date
- February 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,588 users
Product Description
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Reason for Recall
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
Distribution Pattern
International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, and United Kingdom. Latin America- Chile, Colombia and Mexico Asia Pacific (APAC) - Australia, India, Japan, The Republic of Korea, Malaysia, New Zealand, Russia Federation, Singapore, Thailand, and Vietnam. Asia - Hong Kong North America - Canada
Code Information
Product Number - CSS7200 UDI (GTIN.UPN) - 00763000255404