Home / Recalls / Medical Devices
Unomedical As recalls Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhoue
Recalled November 9, 2016 · FDA recall Z-0359-2017 · Unomedical As
Hazard
Tubing detachment · FDA Class II
Units
9,782,880 units
Sold at
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Description
Tubing detachment
Product
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
Manufacturer(s)
Unomedical As
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →