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Class 2 Device Recall Stellant CT Injection System |
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Date Initiated by Firm |
October 10, 2005 |
Date Posted |
November 16, 2005 |
Recall Status1 |
Terminated 3 on August 15, 2007 |
Recall Number |
Z-0154-06 |
Recall Event ID |
33846 |
510(K)Number |
K023183 K033881
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Product Classification |
Injector And Syringe, Angiographic - Product Code DXT
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Product |
Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX |
Code Information |
all serial numbers |
Recalling Firm/ Manufacturer |
Medrad Inc 1 Medrad Dr Indianola PA 15051-9759
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For Additional Information Contact |
Laurence R. Kopyta 412-767-2400 Ext. 3621
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Manufacturer Reason for Recall |
the heat maintainer, an accessory, may overheat and deform the disposable syringe
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/12/05 via certified mail. The notice provided instructions to apply warning labels and disconnect the heat maintainer until a field upgrade kit is available. In case where the heat maintainer is a necessity for specific procedures, the customer is being instructed to observe certain precautions. |
Quantity in Commerce |
4362 units |
Distribution |
The products were shipped to medical facilities nationwide. The products were also shipped to Canada, Isreal, Italy, Denmark, Netherlands, Norway, Great Britain, France, Poland, Germany, Spain, Finland, Belgium, Sweden, Russia, Austraila, Cuba, Mexico, Peru, Hong Kong, Korea, Mylasia, Thialand, Taiwan, Singapore, India, China, Turkey, Saudia Arabia, and Japan |
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 = DXT and Original Applicant = MEDRAD, INC.
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