Recall Z-0137-2015— Animas Corporation
Class II · Terminated
Class II FDA medical device recall by Animas Corporation, initiated 2012-10-25, terminated 2015-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.. 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..
- Recalling firm
- Animas Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-25
- Terminated
- 2015-06-29
- Firm location
- West Chester, PA, United States
Product description
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.