In severe cases, this can cause diabetics to experience prolonged periods of high blood sugar and progress to diabetic ketoacidosis (DKA), a life-threatening condition that requires immediate medical attention.
Insulet did not say how many pod units were affected, but said the recalled insulin pods accounted for about 1.5% of the Omnipods produced each year worldwide.
The company announced that it had received 18 reports of serious adverse events related to dangerous hyperglycemia, including diabetic ketoacidosis and hospitalization. There have been no deaths related to this recall.
Which Omnipod 5 insulin pods have been recalled?
of Lot numbers for recalled insulin pods start with PH1Ufollowed by an eight-digit number. The lot number is printed on the pod tray lid, the bottom of the pod, and the 5-pack pod box.
The company did not provide a list of recalled lot numbers, but said not all lots starting with PH1U were recalled. Users can check the lot number on the Omipod website. Pod lots that do not start with PH1U are unaffected and safe to use.
This recall does not affect continuous glucose monitors (CGMs) or CGM readings.
If you are currently using an insulin pod included in this recall, you should remove it and replace it with an unaffected pod.said the company.
Users with recalled pods can request a free replacement through the Omnipod site. You can also contact Insulet Product Support at 800-641-2049 (24/7) or use the live agent chat at omnipod.com/current-podders.
