OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod Insulin Management System is
FDA device recall Z-0394-2016 · posted 2015-12-15 · Terminated
Recall details
- Recalling firm
- Insulet Corporation
- Reason for recall
- Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 5,179.0 boxes
- Distribution
- Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
- Date initiated
- 2015-11-02
- Date posted
- 2015-12-15
- Date terminated
- 2017-03-07
- Location
- Billerica, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNIPOD INSULIN MANAGMENT SYSTEM (K122953) | Insulet Corporation | 2012-12-07 |