Class 2 Device Recall ARROWgard BluePLUS

• Date Initiated by Firm: October 17, 2017
• Date Posted: February 20, 2018
• Recall Status: Terminated on April 14, 2020
• Recall Number: Z-0653-2018
• Recall Event ID: 79197
• 510(K)Number: K071538
• Product Classification: Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
• Product: Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
• Code Information: Lot number: 23F17D0182
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Karen Boylan; 610-378-0131
• Manufacturer Reason for Recall: These finished good kits may contain the incorrect Springwire Guide (SWG).
• FDA Determined Cause: Process control
• Action: On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.
• Quantity in Commerce: 5,926 total
• Distribution: Distribution US Nationwide
• 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