OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Start
FDA device recall Z-0165-2014 · posted 2013-11-05 · Terminated
Recall details
- Recalling firm
- Insulet Corporation
- Reason for recall
- Alcohol Prep Pads contained within the kit are not properly labeled.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 1,719 starter kits
- Distribution
- Worldwide Distribution - USA Nationwide and the country of Israel.
- Date initiated
- 2013-09-27
- Date posted
- 2013-11-05
- Date terminated
- 2014-03-04
- Location
- Bedford, 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 |