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U.S. Department of Health and Human Services

Class 1 Device Recall OmniPod Insulin Management System

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  Class 1 Device Recall OmniPod Insulin Management System see related information
Date Initiated by Firm November 02, 2015
Date Posted December 15, 2015
Recall Status1 Terminated 3 on March 07, 2017
Recall Number Z-0394-2016
Recall Event ID 72535
510(K)Number K122953  
Product Classification Pump, infusion, insulin - Product Code LZG
Product 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.
Code Information Lot Codes: L41908, L41910, F41935
Recalling Firm/
Manufacturer		 Insulet Corporation
600 Technology Park Dr Ste 200
Billerica MA 01821-4126
For Additional Information Contact Same
978-600-7000
Manufacturer Reason
for Recall		 Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
FDA Determined
Cause 2		 Process change control
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.
Quantity in Commerce 5,179.0 boxes
Distribution Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = INSULET CORPORATION
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