Tandem Diabetes Care Inc 2022-06-22 Health serious FDA
Health · FDA · Recall #FDA-Z-1258-2022
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with… Recall
Issued June 22, 2022 · Tandem Diabetes Care Inc
In June 2022, Tandem Diabetes Care Inc recalled the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
What you should do
- 1 Stop using t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Tandem Diabetes Care Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Tandem Diabetes Care Inc
- Category
- Health
- Recall date
- June 22, 2022
- Units affected
- Not reported
- Sold at
- International distribution in the country of Australia.
- Recall number
- FDA-Z-1258-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Tandem Diabetes Care Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.