Animas Corporation recalls Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the tr…

Recall date

September 6, 2011

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1034-2015

FDA classification

Class II

Brand / firm

Animas Corporation

Sold / distributed

No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.