Events

Recall of Device Recall ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) 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
    57218
  • Event Risk Class
    Class 2
  • Event Number
    Z-0898-2011
  • Event Initiated Date
    2010-11-09
  • Event Date Posted
    2011-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95621
  • 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
    Percutaneous Catheter - Product Code DQY
  • Reason
    One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number cv-15703, but a double-lumen catheter with part number cv-16702 was actually packaged in the kit.
  • Action
    The recalling firm issued Urgent Medical Recall letters dated 11/9/10 to inform their customers of the problem and the need to return any unused product. Customers are to check their stock for the affected product, contact Arrow Customer Service for a Return Authorization Number, and complete the enclosed Recall Acknowledgement & Stock Status Form. For customers with no affected product in stock, the form should still be completed and also faxed to Arrow Customer Service. Affected product should be returned along with the original completed form to Arrow International, Inc. Arrow will replace the affected product once it has been returned. Additional information or clarification can be obtained from Arrow Customer Service at 1-919-361-3964.

Device

Device Recall ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R...
  • Model / Serial
    Lot/Serial Number: CF9065974.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution Only -- Argentina and Columbia.
  • Product Description
    Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. || Permits venous access to the central circulation.
  • 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