Events

Recall of Arrowgard Blue Two Lumen CVC Super 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
    30115
  • Event Risk Class
    Class 3
  • Event Number
    Z-0059-05
  • Event Date Posted
    2004-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35202
  • 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
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
  • Reason
    Labeling error. kits contains the correct components for ak-42802-sk but may have a package label indicating that it is product number ak-22802-sk.
  • Action
    The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.

Device

Arrowgard Blue Two Lumen CVC Super Kit
  • Model / Serial
    Lot number RF4066579
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to distributors in KS and VA, medical facilities in AR, FL, and GA, and a sales representative in FL.
  • Product Description
    Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.
  • 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