Insulet Corporation recalls OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended

Recalled September 16, 2015 · FDA recall Z-2484-2015 · Insulet

Hazard

OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin · FDA Class I

Units

24829 boxes Expanded: 26,230.9 boxes

Sold at

Worldwide Distribution: US (Nationwide) and country of: Switzerland.

Description

OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin

Product

OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Manufacturer(s)

Insulet Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →