FDA-Device2015-09-16Class I
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.
Insulet Corporation
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
Sold states
Worldwide Distribution: US (Nationwide) and country of: Switzerland.
Affected count
24829 boxes Expanded: 26,230.9 boxes
Manufactured in
600 Technology Park Dr Ste 200, N/A, Billerica, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2484-2015Don't want to check this manually?
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