Class 2 Device Recall Churchill Medical Systems, Inc. PORTACATH Tray Kit

• Date Initiated by Firm: May 11, 2012
• Date Posted: June 13, 2012
• Recall Status: Terminated on March 11, 2013
• Recall Number: Z-1803-2012
• Recall Event ID: 61945
• 510(K)Number: K061497
• Product Classification: Heparin, vascular access flush - Product Code NZW
• Product: Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit; ; Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
• Code Information: Product Code AMS-9889CP-7 -- lot 10I86.
• Recalling Firm/ Manufacturer: Vygon Corporation; 103 A Park Drive; Montgomeryville PA 18936-9613
• For Additional Information Contact: 610-539-9300 Ext. 110
• Manufacturer Reason for Recall: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
• FDA Determined Cause: Nonconforming Material/Component
• Action: VYCON sent an URGENT MEDICAL DEVICE RECALL letter dated May 10, 2012, to all affected customers. The firm expanded their recall on May 25, 2012 by sending a second letter with additional lots and products. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected product. Customers should contact Vycon's Customer Service Department at 1-800-473-5414 for a Return Merchandise Authorization number. Customers were instructed to enter the number on the space provided on the Recall Acknowledgment and Inventory Return Form, sign and date form and fax to Vycon at 215-672-6740. Customers should return the affected product as well as the original signed Recall Acknowledgment and Inventory Form using the instructions from Customer Service involving product pick-up. All inventory will be credited. If product was further distributed the Urgent Medical Device Recall letter should be provided to their customers. For questions regarding this recall call 215-672-6740.
• Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
• 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 = NZW and Original Applicant = EXCELSIOR MEDICAL CORP.