Class 2 Device Recall PICC Insertion Tray

• Date Initiated by Firm: February 28, 2018
• Create Date: May 04, 2018
• Recall Status: Terminated on February 19, 2019
• Recall Number: Z-1640-2018
• Recall Event ID: 79752
• Product Classification: Peripheral catheter insertion kit - Product Code OWL
• Product: PICC Insertion Tray, Product Code: AMS-7192CS-4; ; Convenience kit for the insertion of PICCs into the vascular system.
• Code Information: Lot Numbers: 17I040D, 17I041D, 17J016D, 17I002D, 17J015D, 17J018D, UDI: 08498840010648
• Recalling Firm/ Manufacturer: Vygon U.S.A.; 2750 Morris Rd Ste A200; Lansdale PA 19446-6083
• For Additional Information Contact: Marie Benson; 800-473-5414
• Manufacturer Reason for Recall: Potential friction holes may affect the sterility of the product.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Vygon USA, mailed an "URGENT MEDICAL DEVICE RECALL" letter dated 2/28/2018 to affected customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: 1) Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2) Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form; 3) complete and return form via Fax to 215-672-6740 or email to: customerservice@vygonus.com including customer contact information; 4) Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5) Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. Distributors are instructed to: communicate the recall to customers who received the affected product by providing them a copy of the notification. Also, provide a copy of the Recall Acknowledgement and Inventory Return Form to customers. If you have questions or concerns please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
• Quantity in Commerce: 16,520 total products
• Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
• 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.