Events

Recall of Device Recall Arrow Percutaneous Sheath Introducers

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
    Recall
  • Event ID
    51887
  • Event Risk Class
    Class 2
  • Event Number
    Z-1493-2009
  • Event Initiated Date
    2009-02-11
  • Event Date Posted
    2009-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81566
  • 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
    sheath introducer - Product Code KGZ
  • 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.

Device

Device Recall Arrow Percutaneous Sheath Introducers
  • Model / Serial
    All lots of Product codes listed in Z-1489-2009.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Percutaneous Sheath Introducers
  • Manufacturer
    Arrow International Inc

Manufacturer

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