U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing.
You can continue to use your infusion sets by following the advice below.
1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose.
2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
1. Do not attempt to reattach the tubing. Replace the infusion set immediately.
2. Treat any high blood sugar based on guidelines provided by your healthcare professional.
3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set.
The letter included a reply card to be returned.