FDA Recall
Terminated
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.
Recall: Z-0136-2015
·
Initiated June 10, 2014
Recall
- Recall Number
- Z-0136-2015
- Event Number
- 69293
- Firm
- Animas Corporation
- FEI Number
- 3002920072
- Product Code
- N/A
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- June 10, 2014
- Posted
- October 24, 2014
- Terminated
- September 2, 2015
- Address
- 200 Lawrence Dr, West Chester, PA, 19380-3428
Description
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.
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.
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.
Distribution
International Distribution in Israel only.
Quantity
1028