Product Wiki · Recalls · U.S. FDA — Device Enforcement

OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 — recall Z-0394-2016

U.S. FDA — Device Enforcement · United States · 2015-11-02 · Class I

As described by U.S. FDA — Device Enforcement: OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measur

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0394-2016
Date of alert
2015-11-02
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Insulet Corporation
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
Reported risk: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.