Events

Recall of 10 FR Super ArrowFlex Percutaneous Sheath Introducer Set

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
    27540
  • Event Risk Class
    Class 3
  • Event Number
    Z-0088-04
  • Event Initiated Date
    2003-10-22
  • Event Date Posted
    2003-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30027
  • 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
    Introducer, Syringe Needle - Product Code KZH
  • Reason
    Package lid identifies the contents incorrectly.
  • Action
    The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.

Device

10 FR Super ArrowFlex Percutaneous Sheath Introducer Set
  • Model / Serial
    Catalog/Model number CL-07011, Lot number CF03075226
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka
  • Product Description
    10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
  • 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