The OmniPod Insulin Management System Recall News
On August 27, 2015, the U.S. Food and Drug Administration (FDA) confirmed the July 8, 2015 recall of the OmniPod Insulin Management System by the Insulet Corporation. Insulet Corp. initiated the recall of 40,846 boxes of the OmniPod Insulin Management System due to the possibility of failure to deliver insulin. This recall was classified by the FDA as Class I, which is “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
To see original FDA warning visit Insulet Corporation OmniPod Insulin Management System May Fail to Deliver Insulin.
To see FDA recall notice visit Insulet Corporation Issues Recall of OmniPod Insulin Management System.
The OmniPod Insulin Management System Recall
For diabetics, The OmnniPod Insulin Management System is an insulin pump that is meant to be more convenient and portable than traditional scheduled insulin injections. The pump, called a “pod”, is adhered directly on the body, and automatically injects the insulin once activated. The pod delivers the insulin through a tube that pierces the skin through a small opening.
The OmniPod Insulin Management System Recall Due to Chance of Failure
The OmniPod Insulin Management System recall was a result of two possibilities of failure with these devices. According to Insulet Corp. press release, these failures include the following:
1. “The tube either fails to fully insert into the skin or completely retracts after insertion. This failure occurs without an alarm and the Pod will continue to pump insulin.
2. The Pod will provide an audible alarm signal and display a failure. Once the alarm occurs, the Pod will not pump insulin.”
Each of these failures present the same threat, either “can result in inaccurate dosage of insulin which can lead to high blood sugar (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis (DKA), life-threatening conditions, or even death.
As of August 27, 2015, there have been 90 reports to the FDA of defective OmniPod Insulin Management Systems, of which 13 required medical intervention.
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The OmniPod Insulin Management System Recall Information
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.
• Manufactured from: December 2013 to March 2015
• Distributed from: December 2013 to March 2015
• Devices Recalled in the U.S.: 40,846 boxes (10pods/box)
The following OmniPod lots have been voluntarily recalled:
Distribution Catalog Number Description Lot Number
United States POD-ZXP420 OmniPod® Insulin Management System L40806
L40811
L40895
L40976
L41014
L41025
L41067
L41162
L41171
L41197
L41198
L41250
International 14810 OmniPod® Insulin Management System L40771
L40892
L40901
L40905
L40997
L41199
L41208
