Events

Recall of Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port

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
    58331
  • Event Risk Class
    Class 2
  • Event Number
    Z-2048-2011
  • Event Initiated Date
    2011-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99000
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.
  • Action
    The firm, Arrow International, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine any products with the listed lot numbers; complete and return the Immediate Attention Request form via fax to 800-343-2935 indicating how much product they have in stock and whether they need labels. In the event that an alternative approach is needed, the customers are to contact Arrow Customer Service for more information. Once the labels have been received and applied the product can be released from quarantine. An Arrow's Sales Representative will pay a personal visit to their customers and obtain the quantity and the amount of labels they need. If you have any other questions, feel free to contact your local sales representative or Customer Service at 866-396-2111.

Device

Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Val...
  • Model / Serial
    Catalog # PH-09806 -- Lot numbers RF7101122, RF8069650, F8124062, RF0017914, RF0091936
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: PA and NJ.
  • Product Description
    Percutaneous Sheath Introducer Kit || Intended usage: Permits venous access and catheter introduction to the central circulation system
  • 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