Recall Z-0137-2015 ยท LZG Pump, Infusion, Insulin
Animas Corporation
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
| Date | Oct 24, 2014 (initiated Oct 25, 2012) |
| Status | Terminated |
| Reason | Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability. |
| Root cause | Device Design |
| Action | Animas initiated the notification to Distributors by letter, dated July 2012, and Patients and Health Care Professionals were notified by letter in September 2012. The delay in notifying patients and health care professionals was driven by the need to have sufficient inventory of replacement product on hand in order to meet anticipated demand before sending the letters. |
| Quantity | 1938 |
| Distribution | Worldwide Distribution in the countries of France, Italy, Sweden, and UK.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.