Class 2 Device Recall Insulin Pump Model R1000

• Date Initiated by Firm: October 31, 2005
• Date Posted: December 23, 2005
• Recall Status: Terminated on December 23, 2005
• Recall Number: Z-0306-06
• Recall Event ID: 33950
• 510(K)Number: K993184
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: Isulin Pump. Models R1000
• Code Information: Model number R1000
• 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: Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
• FDA Determined Cause: Other
• Action: The recalling firm telephoned the users on 10/31/05 to inform them of the problem and that the pump would be replaced if the user choose to return it.
• Quantity in Commerce: 2 units
• Distribution: The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV.
• 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