FDAFDA · Food and drugs·Recall number Z-0137-2015
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Published November 5, 2014 · Recall initiated: October 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Animas Corporation
- Distributor
- Worldwide Distribution in the countries of France, Italy, Sweden, and UK..
- Lot
- Part Numbers 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 101204-57 101204-63 101205-03 101205-53 101205-56 101205-57 101205-63
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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