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U.S. Department of Health and Human Services

Class 2 Device Recall Insulin Pump Model IR1200

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  Class 2 Device Recall Insulin Pump Model IR1200 see related information
Date Initiated by Firm October 31, 2005
Date Posted December 23, 2005
Recall Status1 Terminated 3 on December 23, 2005
Recall Number Z-0308-06
Recall Event ID 33950
510(K)Number K032257  
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product Isulin Pump. Model IR1200
Code Information Model number IR1200
Recalling Firm/
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 2
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 22 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 and Original Applicant = ANIMAS CORP.