Home / Recalls / Animas Corporation / Z-1034-2015

Z-1034-2015 Class II Terminated

Recalled by Animas Corporation — West Chester, PA

Recall Details

Product Type
Devices
Report Date
February 11, 2015
Initiation Date
September 6, 2011
Termination Date
August 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1235

Product Description

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

Reason for Recall

Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.

Distribution Pattern

No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.

Code Information

Model Number(s): 100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03 101205-03 101200-53 101202-53 101205-53 101200-02 101200-57 101201-57 101202-57 101204-57 101205-57 101200-63 101201-63 101202-63 101204-63 101205-63 101206-63

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-0137-2015 Class II — Animas Vibe Insulin Infusion Pump and System. These products are indicated fo (October 25, 2012)
  • Z-0005-2013 Class II — IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose (July 16, 2012)