Class 2 Device Recall Arrowgard Blue Plus Antimicrobial Multilumen Central Venous Catheter

• Date Initiated by Firm: July 17, 2013
• Date Posted: April 24, 2014
• Recall Status: Terminated on June 02, 2015
• Recall Number: Z-1507-2014
• Recall Event ID: 67834
• 510(K)Number: K993691
• Product Classification: Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
• Product: Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
• Code Information: lot RF2110924
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Road; Reading PA 19605
• For Additional Information Contact: Customer Support; 610-378-0131
• Manufacturer Reason for Recall: Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM
• FDA Determined Cause: Labeling False and Misleading
• Action: Arrow International Inc, ("Arrow") sent a Urgent Medical Device Recall Notification dated July 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot number listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to : 1-866-804-9881. Attn: Customer Service. This will allow us to document the amount of product you have on hand for return Goods Authorization (RGA) number and will provide instructions for the return of product to Arrow International. 3.If you have no affected stock please complete the enclosed Recall Acknowledgement Form and fax it to : 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. For further questions please contact Arrow Customer Service at 1-800-343-2935.
• Quantity in Commerce: 170
• Distribution: US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
• 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