Recall of Device Recall Arrow Peripherally Inserted Central 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
    Peripherally Inserted Central Catheter - Product Code LJS
  • Reason
    Leakage: material not lipid resistant, may crack and/or leak. use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
  • Action
    Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.


  • Model / Serial
    All lots of Product codes listed in Z-1489-2009.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
  • Product Description
    Arrow Peripherally Inserted Central Catheter
  • Manufacturer


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