Call Us Now

(888) 839-4952

Cobalt Chromium Toxicity

Insulet Recalls approximately 400,000 OmniPods





Insulet Corporation launched a voluntary recall of more than 40,000 boxes of the OmniPod Insulin Management System. Each box contains 10 OmniPods meaning there are approximately 400,000 pods that are recalled. The reason for the recall is the devices could have a higher rate of failure than the company’s current manufacturing standards.

According to Insulet, the cannula (the needle for injection) may either completely retract or fail to fully deploy, meaning the patient does not receive the expected insulin dose, or the pod triggers an audible alarm indicating that it will no longer deliver insulin and should be replaced. This problem is reported in over 200 Adverse Event Reports on the Food and Drug Administration (FDA) website, many stating this issue required medical intervention. OmniPods from the affected lots were distributed from December 2013 to March 2015.

Distribution

FDA MedWatch (08/28/15)

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460197.htm


Comments are closed.