Insulet Recalls OmniPod Insulin Management System
Insulet is recalling 26,230 boxes of its OmniPod insulin management system due to the potential for its needle mechanism failing, thereby delaying insulin delivery.
The recall — designated Class 1 by the FDA — covers devices manufactured between July 2015 and August 2015 and distributed in September.
If the mechanism fails or is delayed, the needle will not be inserted in the patient's skin. Ten cases of malfunction have been reported, but the company has not received any word of serious injuries or deaths.
Customers were notified of the issue by the company Nov. 2. — Michael Cipriano