Recall Z-1034-2015— Animas Corporation
Class II · Terminated
Class II FDA medical device recall by Animas Corporation, initiated 2011-09-06, terminated 2015-08-10. 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: Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011..
- Recalling firm
- Animas Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-09-06
- Terminated
- 2015-08-10
- 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
Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.
Data sourced from openFDA. This site is unofficial and independent of the FDA.