Recall Z-0165-2014 ยท LZG Pump, Infusion, Insulin
Insulet Corporation
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting gu
| Date | Nov 5, 2013 (initiated Sep 27, 2013) |
| Status | Terminated |
| Reason | Alcohol Prep Pads contained within the kit are not properly labeled. |
| Root cause | Labeling design |
| Action | Insulet sent an Important Corrective Action Notification letter dated September 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are asked to discontinue use and properly dispose of the affected product. For questions contact Customer Care at (866) 941-0294. |
| Quantity | 1,719 starter kits |
| Distribution | Worldwide Distribution - USA Nationwide and the country of Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM Insulet Corporation, Dec 7, 2012 |