FDA-Device2014-11-05Class II
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Animas Corporation
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.
Sold states
Worldwide Distribution in the countries of France, Italy, Sweden, and UK..
Affected count
1938
Manufactured in
200 Lawrence Dr, N/A, West Chester, PA, United States
Products
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0137-2015Don't want to check this manually?
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