Home / Recalls / Animas Corporation / Z-0137-2015

Z-0137-2015 Class II Terminated

Recalled by Animas Corporation — West Chester, PA

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

Other recalls by Animas Corporation

  • Z-0136-2015 Class II — Animas Vibe Insulin Infusion Pump. This product is indicated for continuous s (June 10, 2014)
  • Z-0993-2013 Class I — Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicate (January 3, 2013)
  • Z-0836-2013 Class III — Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusio (December 17, 2012)
  • Z-0005-2013 Class II — IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose (July 16, 2012)
  • Z-1034-2015 Class II — Animas Vibe Insulin Infusion Pump. This product is indicated for continuous s (September 6, 2011)