Insulet Corporation recalls OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for…

Recall date

July 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2485-2015

FDA classification

Class I

Brand / firm

Insulet Corporation

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.