Events

Recall of Device Recall ARROWgard Blue PLUS Pressure Injectable TwoLumen CVC 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
    70175
  • Event Risk Class
    Class 2
  • Event Number
    Z-1082-2015
  • Event Initiated Date
    2015-01-02
  • Event Date Posted
    2015-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132409
  • 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
    Foreign material found within the kits. the foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
  • Action
    An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.

Device

Device Recall ARROWgard Blue PLUS Pressure Injectable TwoLumen CVC Kit
  • Model / Serial
    product number CDC-42802-P1A, lot number 23F14A0063
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
  • Manufacturer
    Arrow International Inc

Manufacturer

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