Recall Z-1376-2012 ยท LZG Pump, Infusion, Insulin
Animas Corporation
OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
| Date | Apr 6, 2012 (initiated Mar 1, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada and the territory |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM Animas Corp., Jun 24, 2008 |