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Class 2 Device Recall Insulin Pump Model IR1250 |
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Date Initiated by Firm |
October 31, 2005 |
Date Posted |
December 23, 2005 |
Recall Status1 |
Terminated 3 on December 23, 2005 |
Recall Number |
Z-0309-06 |
Recall Event ID |
33950 |
510(K)Number |
K042873
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Product Classification |
Pump, Infusion, Insulin - Product Code LZG
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Product |
Isulin Pump. Model IR1250 |
Code Information |
Model number IR1250 |
Recalling Firm/ Manufacturer |
Animas Corporation 200 Lawrence Dr West Chester PA 19380-3428
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For Additional Information Contact |
Douglas W. Woodruff 610-644-8990 Ext. 1185
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Manufacturer Reason for Recall |
Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LZG and Original Applicant = ANIMAS CORP.
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