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 |
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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.
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510(K) Database | 510(K)s with Product Code = LZG
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