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
Enforcement
- Recall Number
- Z-0359-2017
- Event ID
- 74242
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Unomedical As
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 9, 2016
- Initiation Date
- November 7, 2014
- Classification Date
- November 3, 2016
- Termination Date
- November 16, 2016
- Address
- Aholmvej 1 3 Osted, Roskilde, N/A, Denmark
Description
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
Tubing detachment
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Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
9,782,880 units