Insulet Corporation Issues Voluntary Recall of OmniPod® Insulin Management System
FOR IMMEDIATE RELEASE – August 27, 2015 – Billerica, MA – On July 8, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet's current manufacturing standards. This recall does not affect the OmniPod Personal Diabetes Manager (PDM).
There are two ways in which these Pods can fail at a rate that is higher than Insulet's current standard. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose. Or the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced. Both situations can result in the interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis (DKA).
The affected Pod lots have resulted in 90 Medical Device Reports of which 13 required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
Please check to determine if you have Pods from any of the lots listed below. The lot number is located on the Pod tray lid label and is also laser etched on the side of each individual Pod. The lot number is also located on the box of OmniPods. Consumers who have Pods from the affected lots should stop using them and return the pods for replacement.
Click the link to read the list of lot numbers.
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