OmniPod Insulin Management System Recall [US]


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US/Silver Spring: FDA LogoInsulet Corporation recalls an estimated 408,460 OmniPod Insulin Management System Pods due to possible operational failure, a serious health and safety hazard. FDA: http://ht.ly/Ryu0A

Direct link: http://www.fda.gov/Safety/Recalls/ucm460169.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drug Administration Systems are subject to this recall:

  • OmniPod (Pod) Insulin Management System, catalog number: POD-ZXP420
    Distribution: United States; lot numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250
  • OmniPod (Pod) Insulin Management System; catalog number: 14810
    Distribution: International; lot numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208

OmniPods from the affected lots were distributed to customers from December 2013 to March 2015.

According to the FDA, there are two ways in which these Pods can fail at a rate that is higher than Insulet’s current standard:

  1. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected Insulin dose.
  2. In addition, the Pod may trigger an audible alarm indicating it will no longer deliver Insulin and will need to be replaced.

Both types of failures 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.

If you believe you have purchased or have in your possession the recalled Drug Administration Systems, please do not use them. Instead, kindly return the product to the distributor from which you received them for a full refund.

Insulet has notified its distributors and customers by email, FedEx, and phone calls and is arranging for return and replacement of all recalled product. If you have any questions about this recall, please contact the company at 1-855-407-3729 at any time.

Please note: Insulet has also notified Competent Authorities in Austria, Germany, Italy, Netherlands, Norway, Sweden, Switzerland and the UK concerning this recall.

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Additional information about this recall:
Recalls Direct RIN: 5768-2015
More recalls? Back to the main Recalls Direct page: http://www.RecallsDirect.com/
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.

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