Reported Nov 5, 2014 · Terminated

Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of…

Animas Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Animas Corporation · 200 Lawrence Dr · West Chester, PA · 19380-3428

Is this the product you have?

Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

Lot codes and dates: Part Numbers
67 of 67 codes
101200-57
100512-57
100510-02
100510-03
100510-04
100510-53
100510-56
100510-57
100510-63
100510-67
100511-02
100511-03
100511-04
100511-53
100511-56
100511-57
100511-63
100512-02
100512-02
100512-03
100512-04
100512-53
100512-56
100512-57
100512-63
100514-02
100514-03
100514-04
100514-53
100514-56
100514-57
100514-63
100515-02
100515-03
100515-04
100515-53
100515-56
100515-57
100515-63
101200-02
101002-03
101002-53
101002-56
101002-57
101002-63
101201-02
101201-03
101201-53
101210-56
101201-57
101201-63
101202-02
101202-03
101202-04
101202-53
101202-57
101202-63
101204-03
101204-04
101204-53
Amount recalled: 1938

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous…

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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