Events

Recall of Radial Artery Catheterization Kit w/sharp safety features

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
    74986
  • Event Risk Class
    Class 2
  • Event Number
    Z-2741-2016
  • Event Initiated Date
    2016-08-08
  • Event Date Posted
    2016-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149019
  • 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
    Wire, guide, catheter - Product Code DQX
  • Reason
    Shipping carton labeling error.
  • Action
    Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990.

Device

Radial Artery Catheterization Kit w/sharp safety features
  • Model / Serial
    Device Listing # D025180
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to OH, IN, TN, NC, and KY.
  • Product Description
    Radial Artery Catheterization Kit with Sharps Safety Features || Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
  • 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