Events

Recall of Device Recall Arrow TwoLumen CVC Kit with Blue Flex Tip Catheter

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
    65829
  • Event Risk Class
    Class 2
  • Event Number
    Z-1965-2013
  • Event Initiated Date
    2013-07-31
  • Event Date Posted
    2013-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120336
  • 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, percutaneous - Product Code DQY
  • Reason
    Arrow is recalling the product due to a labeling inconsistency. one portion of the lidstock states the kit contains a 3-lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-lumen.
  • Action
    An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.

Device

Device Recall Arrow TwoLumen CVC Kit with Blue Flex Tip Catheter
  • Model / Serial
    Catalog # AK-17702-CDC, lot # RF2083258
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
  • Product Description
    Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
  • 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