Guardian Connect App CSS7200 used on the iPhone recall
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Why was Guardian Connect App CSS7200 used on the iPhone recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI - (01)00643169693142(10)
- Product
- Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
- Recalling firm
- Medtronic Inc.
- Quantity
- Approximately 9,328 registered users
- Distribution
- 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.
- Recall date
- May 15, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)