Animas IR 1250 Insulin Pump.
This recall has been terminated (originally issued June 25, 2005).
- Company
- Animas Corporation
- Recall Initiated
- April 11, 2005
- Posted
- June 25, 2005
- Terminated
- January 24, 2006
- Recall Number
- Z-0929-05
- Quantity
- 2081 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
pump failed to respond to keypad button pressess after using the food database feature
Distribution
The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide.
Lot / Code Info
Model IR1250
Root Cause
Other
Action Taken
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.