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

Recall Z-0393-2016 — OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 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 meas

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0393-2016
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

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.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.

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.

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