Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (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 DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (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 1. Model/REF Number: POD-BLE-I1-525 (5-Pack)Model PD1U11012421Model PD1U11022421Model PD1U02152521Model PD1U02192521Model PD1U04242522Model PD1U10282522Model PD1U10292521Model PD1U10302521Model PD1U10312521Model PD1U11032521Model PD1U11042521Model PD1U09102421Model PD1U09092421Model PD1U09062421Model PD1U10242421Model PD1U10252421Model PD1U10282421Model PD1U10292421Model PD1U10312421Model PD1U11042421. 3. Model/REF Number: BLE-I1-529 (10-Pack)Model PD1U11182421Model PD1U11202421Model PD1U09042421Model PD1U11132421UPC 20385082000051UPC 10385082000023UPC 20385082000020UPC 20385082000112UPC 10385082000115

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.