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Animas Corporation recalls Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of in
Recalled November 5, 2014 · FDA recall Z-0137-2015 · Animas
Hazard
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. · FDA Class II
Units
1938
Sold at
Worldwide Distribution in the countries of France, Italy, Sweden, and UK..
Description
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.
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.
Manufacturer(s)
Animas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →