Events

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
    Recall
  • Event ID
    35959
  • Event Risk Class
    Class 2
  • Event Number
    Z-0030-2007
  • Event Initiated Date
    2006-06-20
  • Event Date Posted
    2006-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47262
  • 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
    pressure catheter - Product Code NVM
  • Reason
    The print identifying the two extension lines, cvp proximal and pa distal, are reversed.
  • Action
    Recall letter was sent to customers on 6/20/2006 by US mail.

Device

Device Recall Arrow
  • Model / Serial
    MF5124329
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.
  • Product Description
    Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA