Events

Recall of Device Recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Cat

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
    55933
  • Event Risk Class
    Class 2
  • Event Number
    Z-2274-2010
  • Event Initiated Date
    2010-06-07
  • Event Date Posted
    2010-08-25
  • 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=92259
  • 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 - Product Code KGZ
  • Reason
    Sterility not assured. the stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. sterility of the affected product cannot be guaranteed.
  • Action
    June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.

Device

Device Recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for us...
  • Model / Serial
    Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    All affected product was distributed to one foreign consignee: Arrow Japan Ltd.
  • Product Description
    Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
  • 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