Class 2 Device Recall Winged Infusion Set

• Date Initiated by Firm: November 16, 2010
• Date Posted: February 16, 2011
• Recall Status: Terminated on May 01, 2012
• Recall Number: Z-1333-2011
• Recall Event ID: 57295
• 510(K)Number: K020544
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683 Item # FIY-2210 Intended use: Intravascular Administration Set
• Code Information: Lot Number: 1010034
• 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: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
• FDA Determined Cause: Vendor change control
• Action: The firm, Churchill Medical/Vygon, sent an "URGENT MEDICAL DEVICE RECALL" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return product with form to: Vygon, 103A Park Drive, Montgomeryville, PA 18936, and if the customer is a distributor, they were to provide their customers with a copy of this notification and attached form. Note: An additional follow up communication will be provided to the customers after reconciliation of the returned inventory and all inventory will be credited or replaced. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.
• Quantity in Commerce: 1380 units
• Distribution: Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.
• 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