Recall Z-0359-2017 ยท FPA Set, Administration, Intravascular
Unomedical As
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
| Date | Nov 7, 2014 |
| Status | Terminated |
| Reason | Tubing detachment |
| Root cause | Device Design |
| Action | 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 bloo |
| Quantity | 9,782,880 units |
| Distribution | Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan. |
| FDA record | Open on fda.gov |