Recall Z-0136-2015 ยท N/A
Animas Corporation
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
| Date | Oct 24, 2014 (initiated Jun 10, 2014) |
| Status | Terminated |
| Reason | Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen. |
| Root cause | Employee error |
| Action | A recall notification letter, dated June 2014, was sent to the recalling firm's sole customer, TriTech Biomed, in Israel, to notify them about the product, problem, and action to be taken. The distributor sent letters to their customers on July 16, 2014. |
| Quantity | 1028 |
| Distribution | International Distribution in Israel only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.