Class 2 Device Recall Stellant Syringe Kit

• Date Initiated by Firm: October 08, 2004
• Date Posted: October 22, 2004
• Recall Status: Terminated on January 25, 2005
• Recall Number: Z-0039-05
• Recall Event ID: 30240
• 510(K)Number: K023183
• Product Classification: Injector And Syringe, Angiographic - Product Code DXT
• Product: Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
• Code Information: Lot number 45535 exp 9/2008
• 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 component tearing the outer packaging
• FDA Determined Cause: Other
• Action: The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.
• Quantity in Commerce: 1650 kits
• Distribution: The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX.
• 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.