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U.S. Department of Health and Human Services

Class 2 Device Recall Stellant Dual Syringe Kit

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  Class 2 Device Recall Stellant Dual Syringe Kit see related information
Date Initiated by Firm November 03, 2004
Date Posted November 24, 2004
Recall Status1 Terminated 3 on April 20, 2005
Recall Number Z-0257-05
Recall Event ID 30432
510(K)Number K023183  
Product Classification Injector And Syringe, Angiographic - Product Code DXT
Product Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
Code Information Lot Numbers 38821 through 45666 for each catalog number, Expiration Date October 2008.
Recalling Firm/
Manufacturer
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
Sterility can be compromised by a tear in the outer packaging.
FDA Determined
Cause 2
Other
Action The recalling firm issued recall letters dated 11/1/04 to their consignees informing them of the problem and the need to return the product.
Quantity in Commerce 875, 798 kits
Distribution The product was shipped to distributors and medical facilities nationwide. The product was also shipped to Saudia Arabia, Kuwaitt, Maylasia, Israel, Chile, Hong Kong, Great Britain, Denmark, Germany, China, Canada, France, Taiwan, Thailand, Singapore, Finland, Phillipines, Norway, Netherlands,, Spain, Mexico, Czech, Japan, Italy, Sweden, Brazil, Belgium, and Austraila.
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.
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