Recall of Device Recall Arrowgard Blue Plus Antimicrobial Multilumen Central Venous Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • Reason
    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.
  • 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.


  • Model / Serial
    lot RF2110924
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
  • Product Description
    Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
  • Manufacturer


  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Manufacturer Parent Company (2017)
  • Source