| Class 2 Device Recall Insulin Pump Model IR1250 | |
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 |
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 |
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 | 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
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