Omnipod insulin pods recalled for potential under-delivery due to manufacturing defect
What this means
Insulet found a manufacturing issue in certain lots of Omnipod 5, Omnipod DASH, and Omnipod Eros pods that could cause insulin to leak instead of being fully delivered into the body. The leak occurs when a small tear develops in the tubing just above the skin. In some cases, users may not notice the problem, which can lead to high blood sugar levels and, in severe cases, diabetic ketoacidosis.
- Check your Pod lot number at omnipod.com/current-podders or by calling 1-800-641-2049 to see if it is affected.
- If your Pod lot is affected, stop using it and replace it with an unaffected Pod.
- Watch for wetness on your skin, Pod adhesive, or the smell of insulin — signs of a leak.
- Request free replacement Pods from Insulet if your lot is on the recall list.
The agency's original wording
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation, Inc. (NASDAQ: PODD) (“Insulet” or the “Company”) today announced a voluntary Medical Device Correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue, identif
Official notice
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-pods-us-and-affectedWant us to check the next one for you?
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