Recall Z-2484-2015 ยท LZG Pump, Infusion, Insulin
Insulet Corporation
OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
| Date | Sep 4, 2015 (initiated Jul 13, 2015) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 o |
| Quantity | 24829 boxes Expanded: 26,230.9 boxes |
| Distribution | Worldwide Distribution: US (Nationwide) and country of: Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM Insulet Corporation, Dec 7, 2012 |