Recall Z-0293-2009 ยท LZG Pump, Infusion, Insulin
Animas Corporation
Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain blood glucose targets.
| Date | Nov 25, 2008 (initiated Aug 4, 2008) |
| Status | Terminated |
| Reason | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions. |
| Quantity | 990 units |
| Distribution | Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032257 | MODEL IR 1200 INSULIN PUMP Animas Corp., Oct 16, 2003 |