Class 2 Device Recall RUSCH

• Date Initiated by Firm: June 30, 2011
• Date Posted: August 03, 2011
• Recall Status: Terminated on April 29, 2014
• Recall Number: Z-2934-2011
• Recall Event ID: 59356
• 510(K)Number: K896729
• Product Classification: Catheter, urological - Product Code KOD
• Product: RUSCH, GB: Female Catheter, All Purpose PVC, 12 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
• Code Information: Product number: 238300120, Lot numbers: 102727, 105235, 106285, 113977, 113977-1, 116421, 117539, 117596, 118055, 119407, 121555, 122279, 122741, 122742, 127595, 127596, 129921, 130638, 132295, 142577, 142578, 142686, 145826, 224511, 310436, 322170, 335516, 335517, 339565, 340215, 342048, 342049, 346327, 350057, 350058, 351722, 355193, 355194, 359275, 359991, 380181, 381731, 407775 and 238300120.
• Recalling Firm/ Manufacturer: Teleflex Medical; 4024 Stirrup Creek Dr; Durham NC 27703-9000
• For Additional Information Contact: Jennifer Thompson; 610-478-3131
• Manufacturer Reason for Recall: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
• FDA Determined Cause: Other
• Action: Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990
• Quantity in Commerce: see line 1.
• Distribution: Worldwide Distribution and (USA) Nationwide Distribution.
• 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 = KOD