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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow AGB MultiLumen CVC Kit

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  Class 2 Device Recall Arrow AGB MultiLumen CVC Kit see related information
Date Initiated by Firm July 18, 2019
Create Date October 24, 2019
Recall Status1 Terminated 3 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/
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact SAME
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 2
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 and Original Applicant = ARROW INTL., INC.