Class 2 Device Recall Vygon

• Date Initiated by Firm: January 15, 2015
• Date Posted: April 21, 2015
• Recall Status: Terminated on February 25, 2016
• Recall Number: Z-1469-2015
• Recall Event ID: 70369
• 510(K)Number: K021395 K070705 K963981
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
• Code Information: 1303123 1305003 1305008 1305049 1306097
• Recalling Firm/ Manufacturer: Churchill Medical Systems, Inc.; 87 Venture Drive; Dover NH 03820-5914
• For Additional Information Contact: 800-473-5414
• Manufacturer Reason for Recall: Potential for leaking caused by insufficient bond between needleless device and female luer.
• FDA Determined Cause: Process design
• Action: Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them. If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return. Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
• Quantity in Commerce: 2350
• Distribution: Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
• 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 = FPA; 510(K)s with Product Code = FPA