Class 2 Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1

• Date Initiated by Firm: January 21, 2013
• Date Posted: March 06, 2013
• Recall Status: Terminated on September 10, 2013
• Recall Number: Z-0914-2013
• Recall Event ID: 64464
• 510(K)Number: K013871
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010; ; Huber type needle set used for the infusion of medical fluids into implantable ports.
• Code Information: Lot #1210099
• Recalling Firm/ Manufacturer: Churchill Medical Systems, Inc.; 87 Venture Drive; Dover NH 03820-5914
• For Additional Information Contact: 603-743-5988
• Manufacturer Reason for Recall: The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
• FDA Determined Cause: Under Investigation by firm
• Action: Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at customerservice@vygonus.com. For questions regarding this recall call 603-743-5988.
• Quantity in Commerce: 2340
• Distribution: Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
• 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 and Original Applicant = HORIZON MEDICAL PRODUCTS, INC.