FDA Device

Animas IR 1250 Insulin Pump.

Hazard

pump failed to respond to keypad button pressess after using the food database feature

What You Should Do

Remedy

The recalling firm issued a recall notice dated 4/11/05 to all patients and healthcare providers via first class mail. The letter instructs the patient to reset the pump, thus correcting any problems caused by the software bug, and to discontinue use of the food database. All distributors were contacted by phone on 4/12/05 and instructed to return all pumps in their inventory. On 4/25/05, the recalling began emailing and telephoning patients to arrange for replacement and return of the devices.

Products

Animas IR 1250 Insulin Pump.
Brand
Animas Corporation
UPC
Model IR1250

Units Affected

2081 units