Recall Z-0394-2016 ยท LZG Pump, Infusion, Insulin
Insulet Corporation
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.
| Date | Dec 15, 2015 (initiated Nov 2, 2015) |
| Status | Terminated |
| Reason | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. |
| Root cause | 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 | 5,179.0 boxes |
| Distribution | Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM Insulet Corporation, Dec 7, 2012 |