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Animas Corporation recalls Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the
Recalled February 11, 2015 · FDA recall Z-1034-2015 · Animas
Hazard
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. · FDA Class II
Units
1235
Sold at
No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
Description
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.
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.
Manufacturer(s)
Animas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →