Recall Z-3017-2011 ยท LZG Pump, Infusion, Insulin
Animas Corporation
Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.
| Date | Aug 12, 2011 (initiated Jul 29, 2011) |
| Status | Terminated |
| Reason | Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery. |
| Root cause | Mixed-up of materials/components |
| Action | Animas Corporation sent an "Urgent: Insulin Pump Recall" letter dated July, 29 20011 to all affected customers. The letter included affected product and problem. They requested anyone who received the pump to send it back to Animas and a replacement pump will be sent at no charge. For additional information contact the Customer Support Department at (877) 937-7867. |
| Quantity | 380 |
| Distribution | Worldwide Distribution: Nationwide (USA) distribution including the states of CA, CO, MA, and MD; and the countries of Australia, Finland, France, Israel, Italy, Sweden and the U.K. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.