Class 2 Device Recall ARROW MultiLumen Central Venous Catheterization Set with Blue FlexTip Catheter

• Date Initiated by Firm: May 11, 2018
• Create Date: June 29, 2018
• Recall Status: Terminated on April 20, 2020
• Recall Number: Z-2336-2018
• Recall Event ID: 80227
• 510(K)Number: K862056
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E; ; Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
• Code Information: 71F18A0682
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Customer Service; 610-378-0131
• Manufacturer Reason for Recall: The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.
• FDA Determined Cause: Employee error
• Action: On May 11, 2018, the firm sent an Urgent Medical Device Recall letter to affected customers via FedEx. Distributors were instructed to take the following actions: 1. Immediately discontinue distribution and quarantine any products with the product code and lot number listed above. 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Arrow International Customer Service for more information at 1-866-396-2111. 4. To return affected products from your inventory, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. This will allow us to document completion of the recall. 6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter.
• Quantity in Commerce: 1200
• Distribution: Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
• 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 = DQY and Original Applicant = ARROW INTL., INC.