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 measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
FDA Recall Z-0394-2016 · Posted 2015-12-15
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Recalling FirmInsulet Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2015-11-02
Date Terminated2017-03-07
Product Quantity5,179.0 boxes
Reason for Recall
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Firm Action
Insulet issued on 11/2/15 an URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes the problem that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle.
Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls.
Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification.
Root Cause
Process change control
Distribution Pattern
Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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