In severe cases, this can cause people with diabetes to experience extended periods of high blood sugar that may progress to diabetic ketoacidosis (DKA), a life-threatening condition that requires immediate medical attention.
Insulet did not specify how many pod units were affected, but said the recalled insulin pods accounted for about 1.5 percent of Omnipods produced globally every year.
The company said it had received 18 reports of serious adverse events related to dangerously high blood sugar, including diabetic ketoacidosis and hospitalization. There have been no deaths linked to this recall.
Which Omnipod 5 Insulin Pods Were Recalled?
The recalled insulin pods have lot numbers beginning with PH1U, followed by an 8-digit number. The lot number is printed on the pod tray lid, the bottom of the pod, and on the 5-pack pod box.
The company did not provide a list of recalled lot numbers, but it said that not all lots starting with PH1U have been recalled. Users can check their lot numbers at the Omipod website. Pod lots that don’t start with PH1U are not affected and are safe to use.
The recall does not affect continuous glucose monitors (CGM) or CGM readings.
If you are currently using an insulin pod included in this recall, you should take it off and replace it with an unaffected pod, the company said.
Users with recalled pods can request free replacements from the Omnipod site. They can also reach out to Insulet Product Support at 800-641-2049 (available 24/7) or use the live agent chat at omnipod.com/current-podders.
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