Recall of Device Recall Arrow

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
    Central Venous Catheterization Set - Product Code DQY
  • Reason
    The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.
  • Action
    Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.


  • Model / Serial
    Catalog number: CS-14502, Lot numbers: RF7019488 and RF7029944.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.
  • Product Description
    Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
  • Manufacturer


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