Class 2 Device Recall Stellant Dual Syringe Kit

• Date Initiated by Firm: November 03, 2004
• Date Posted: November 24, 2004
• Recall Status: Terminated 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: 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