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U.S. Department of Health and Human Services

Class 1 Device Recall Insulet OmniPod

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  Class 1 Device Recall Insulet OmniPod see related information
Date Initiated by Firm July 13, 2015
Date Posted September 04, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-2485-2015
Recall Event ID 71651
510(K)Number K122953  
Product Classification Pump, infusion, insulin - Product Code LZG
Product OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Code Information Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208  Expanded Recall: 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		 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
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Insulet Corporation, sent an "URGENT: Voluntary Device Recall" letter dated 7/13/2015 to each consignee/customer via Email notification (where possible) on 7/13/15 as well as Federal Express. Customers not responding to the email or Federal Express will receive follow up phone calls. The letter described the product, problem and actions to e taken. The customers were instructed to do the following: If you have Pods from any of these lots, set them aside, we will replace them at no charge; arrange for return and replacement by choosing one of the following methods: 1. Complete the online form at https://www.myomnipod.com/podinfo (fastest method). 2. Return the enclosed reply card by mail or fax to 1-855-407-3729. 3. Contact Insulet Customer Care by calling 1-855-407-3729 (any time day or night). If you do not have any unused Pods form these lots, reply using one of the methods above. If you have any question, contact Acting VP RA/QA at 978-600-7000. EXPANDED RECALL: Insulet Corp. issued on 11/2/15 the URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes problem of 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 16,017 boxes. Expanded Recall: 5,179.0 boxes
Distribution Worldwide Distribution: US (Nationwide) and country of: Switzerland.
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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