OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
FDA device recall Z-1376-2012 · posted 2012-04-06 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue.
- Action taken
- The firm initiated their recall on March 1, 2012 and sent Urgent Notification letters dated March 6, 2012 to all consignees by UPS with delivery confirmation. Customers were notified of the issue and the appropriate steps to take in order to mitigate the issue. A Web Letter for users was also posted to the Animas web site. Questions were directed to (855) 230-7577.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 91,239
- Distribution
- Worldwide Distribution, (USA) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,
- Date initiated
- 2012-03-01
- Date posted
- 2012-04-06
- Date terminated
- 2013-12-24
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639) | Animas Corp. | 2008-06-24 |