Recall Z-0136-2015— Animas Corporation
Class II · Terminated
Class II FDA medical device recall by Animas Corporation, initiated 2014-06-10, terminated 2015-09-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Animas Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-10
- Terminated
- 2015-09-02
- Firm location
- West Chester, PA, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.