Recall Z-0955-2009 ยท LZG Pump, Infusion, Insulin
Animas Corporation
Meter Remote for OneTouch Ping Glucose Management System
| Date | Mar 3, 2009 (initiated Oct 27, 2008) |
| Status | Terminated |
| Reason | incorrect dosing recommendation |
| Root cause | Software design |
| Action | The recalling firm issued Urgent: Medical Device Correction letters dated 10/27/08 to their customers/user to inform them of the problem. The letter stated that the firm was in the process of correcting the issue and that a new OneTouch Ping Meter-Remote would be provided as soon as one became available. In the interim, customers could still safely use their OneTouch Ping System provided that they use the ezCarb calculator on the meter-remote when it is paired and communicating with the pump. The letter listed guidelines to ensure that the device is properly communicating with the pump. Th |
| Quantity | 5093 units |
| Distribution | Nationwide Distribution --- including states of KY, UT, FL, OH, MA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM Animas Corp., Jun 24, 2008 |