Class 2 Device Recall IR 1200 Insulin Pump

• Date Initiated by Firm: September 28, 2004
• Date Posted: November 19, 2004
• Recall Status: Terminated on March 10, 2005
• Recall Number: Z-0211-05
• Recall Event ID: 30166
• 510(K)Number: K032257
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
• Code Information: Model IR 1200
• FEI Number: 3002920072
• Recalling Firm/ Manufacturer: Animas Corporation; 200 Lawrence Dr; West Chester PA 19380-3428
• For Additional Information Contact: Doug Woodruff; 610-644-8990 Ext. 1185
• Manufacturer Reason for Recall: Suspend mode not functioning properly
• FDA Determined Cause: Other
• Action: The recalling firm issued a notice entitled 'Important Safety Information Regarding the Animas IR 1200 Pump' dated 9/28/04 to the health care professionals and distributors. The letter informed the reader of the problem and to use an alternate feature. Health care professionals should notify patients of the problem.
• Quantity in Commerce: 7395 units
• Distribution: The products are shipped to diabetic supply companies in FK, NE, NV, NJ, NY, OH, OK, TX, VA, and WA then further shipped to patients nationwide. The products were shipped to government accounts in IL, MD, and SC. The product was also shipped to a supply company in Israel.
• 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