Class 2 Device Recall Animas IR 1250 Insulin Pump

• Date Initiated by Firm: April 11, 2005
• Date Posted: June 25, 2005
• Recall Status: Terminated on January 24, 2006
• Recall Number: Z-0929-05
• Recall Event ID: 31760
• 510(K)Number: K042873
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: Animas IR 1250 Insulin Pump.
• Code Information: Model IR1250
• FEI Number: 3002920072
• Recalling Firm/ Manufacturer: Animas Corporation; 200 Lawrence Dr; West Chester PA 19380-3428
• For Additional Information Contact: Douglas W. Woodruff; 610-644-8990 Ext. 1185
• Manufacturer Reason for Recall: pump failed to respond to keypad button pressess after using the food database feature
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 2081 units
• Distribution: The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LZG