FDA-Device2016-11-09Class II
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
Unomedical As
Hazard
Tubing detachment
Sold states
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Affected count
9,782,880 units
Manufactured in
Aholmvej 1 3 Osted, Roskilde, Denmark
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0359-2017Don't want to check this manually?
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