Events

Recall of Device Recall Femoral Arterial Line Catheterization Kit

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
    74489
  • Event Risk Class
    Class 2
  • Event Number
    Z-2202-2016
  • Event Initiated Date
    2016-06-02
  • Event Date Posted
    2016-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147776
  • 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
    Labeling error. some shipping cartons labeled as ask-04018-vuh contained ask-04020-vuh kits; and some shipping cartons labeled as ask-04020-vuh contained ask-04018-vuh kits.
  • Action
    Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Femoral Arterial Line Catheterization Kit
  • Model / Serial
    Lot/Batch Numbers: 23F14M0829, 23F14M0986
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution in the states of TN and KY.
  • Product Description
    Femoral Arterial Line || Catheterization Kit with Sharps Safety Features || 510K 810675, product code DQX, Device Listing D025180 || Material ASK-04018-VUH || Product Usage: || The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
  • 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