Class 2 Device Recall Arrow AGB MultiLumen CVC Kit

• Date Initiated by Firm: July 18, 2019
• Create Date: October 24, 2019
• Recall Status: Terminated on November 10, 2020
• Recall Number: Z-0192-2020
• Recall Event ID: 83456
• 510(K)Number: K993691
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied.
• Code Information: Lot Number: 13F18L0759
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: SAME; 610-378-0131
• Manufacturer Reason for Recall: Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length
• FDA Determined Cause: Packaging process control
• Action: Teleflex issued notification letter dated July 17, 2019 issued via FedEx 2-day mail identifies the problem, health risk and action to take: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. If you do have stock a customer service representative will contact you to arrange issuing correct labels to relabel the product. Questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
• Quantity in Commerce: 745 eaches
• Distribution: US Nationwide distribution.
• 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 = FOZ