Class 2 Device Recall SILHOUETTE XTRAFLO

• Date Initiated by Firm: May 20, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on April 14, 2010
• Recall Number: Z-2219-2008
• Recall Event ID: 48688
• 510(K)Number: K060673 K040760 K991219
• Product Classification: Stent Positioner - Product Code FAD
• Product: SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.
• Code Information: LOT NUMBERS: 1058016, 1059244 and 1060923
• FEI Number: 2027111
• Recalling Firm/ Manufacturer: Applied Medical Resources Corp; 22872 Avenida Empresa # 3; Rancho Santa Margarita CA 92688-2650
• For Additional Information Contact: Frans VandenDroek; 949-713-8369
• Manufacturer Reason for Recall: The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On May 20, 2008, Applied Medical began distribution of an Recall Notice with fax-back attachment ( Recall Notification Confirmation Form ) to all customers in the United States via Applied's Direct Sales Force. The Notice informed customers of the problem that caused the initiation of the recall and requested they complete and fax-back the Recall Notification Confirmation Form . The letter also instructed their customers to remove and return affected product to Applied Medical immediately via FedEx. If the customers had an questions they were to contact Mr. Frans VandenBroek at (949) 7l3-8369 or by e-mail at fvandenbroekappliedmedical.com.
• Quantity in Commerce: 103
• Distribution: Nationwide to: AL, AZ, CA, CO, DC, FL, GA, KY, IL, LA, MI, MN, NC, NJ, NY, PA, TN, TX, WA, WI and Worldwide to: Australia & South Africa
• 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 = FAD; 510(K)s with Product Code = FAD