Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
Insulet Corporation
The hazard
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model PH1U01102521Model PH1U12102421Model PH1U12172421Model PH1U11212421Model PH1U11252421Model PH1U11222421Model PH1U12092421Model PH1U09112421Model PH1U11262421Model PH1U04032521Model PH1U12022421Model PH1U12182421Model PH1U04302524Model PH1U05022521Model PH1U01222521Model PR1U11202533Model PH1U09122421Model PH1U10102421Model PH1U12122421Model PH1U01302522Model PH1U02222521Model PH1U05052521Model PH1U10042421Model PH1U12102412Model PH1U01312521UPC 20385083000579UPC 10385083000527UPC 20385083000425UPC 10385083000411UPC 2038508300043UPC 20385083000548UPC 20385083000135UPC 10385083000114Would you have heard about this one?
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