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U.S. Department of Health and Human Services

Class 2 Device Recall Stellant CT Injection System

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  Class 2 Device Recall Stellant CT Injection System see related information
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  
Product Classification Injector And Syringe, Angiographic - Product Code DXT
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/
Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Laurence R. Kopyta
412-767-2400 Ext. 3621
Manufacturer Reason
for Recall
the heat maintainer, an accessory, may overheat and deform the disposable syringe
FDA Determined
Cause 2
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

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 = DXT and Original Applicant = MEDRAD, INC.