Recall Z-0166-2014 ยท LZG Pump, Infusion, Insulin
Insulet Corporation
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin M
| 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 | 5,050 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 |