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rachelpatel1796 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
One product that was on recall by the FDA was the Insulin Corporation Omnipod Insulin Management System. This product is basically a small pod that you fill with insulin, attach to any part of the body that will receive the injection, and press start for it to be delivered. However, there was a huge recall on the product because the needle may fail to deliver the insulin, the main point of the product. The product is also small and portable, which makes it easy for diabetics to use, since they may forget to take their shots at the right time. Since the pod is connected wirelessly to another device, you can input the right time the shots can be injected. Thus, if the needle does not inject the insulin, it can lead to hyperglycemia (high blood sugar) and cause life-threatening issues and even death. In this particular case, there have been 10 cases where the pod showed not to be working. It might not have been an FDA issue than it was a manufacturing issue. All pods should be guaranteed to work and last, and they should come with instructions on how to make sure they are working properly.