Z-0137-2015 Class II Terminated
FDA device recall Z-0137-2015 was initiated by Animas Corporation on October 25, 2012 and is designated Class II. Reason for recall: 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 imp… The recall status is terminated (terminated June 29, 2015). Affected quantity: 1938.
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2014
- Initiation Date
- October 25, 2012
- Termination Date
- June 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1938
Product Description
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution in the countries of France, Italy, Sweden, and UK..
Code Information
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