Events

Recall of Arrow MultiLumen Central Venous Catheterization

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
    69290
  • Event Risk Class
    Class 2
  • Event Number
    Z-0076-2015
  • Event Initiated Date
    2014-09-18
  • Event Date Posted
    2014-10-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130176
  • 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 international, inc. has initiated a voluntary recall for product code ak- 12703, lot number rf3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. all kits packaged within the corrugate are correctly labeled. there is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.
  • Action
    Arrow International sent an Medical Device Advisory Notifications letter dated September 18, 2014, sent to direct accounts to notify them about the product, problem, and actions to be taken. Arrow International, Inc. (Arrow) is notifying customers that the label on the outer corrugate for the above mentioned product code and lot number is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date. Arrow International, Inc. is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Arrow MultiLumen Central Venous Catheterization
  • Model / Serial
    Catolog No - AK-12703 lot number RF3039028
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.
  • Product Description
    Multi-Lumen Central Venous Catheterization || Kit
  • 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