Events

Recall of Device Recall Percutaneous Sheath Introducer (PSI) Arrow Select Kit

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
    54091
  • Event Risk Class
    Class 2
  • Event Number
    Z-1538-2010
  • Event Initiated Date
    2009-12-15
  • Event Date Posted
    2010-05-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87460
  • 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 Accessories - Product Code KGZ
  • Reason
    Some central venous catheter sets had the incorrect lid stock.
  • Action
    Consignees were notified by an Urgent Medical Device Recall letter on/about 12/15/2009. The letter identified the affected product and stated the reason for the recall. Customers were instructed to immediately check their stock and cease use, distribution, and quarantine affected product. They are also to contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to return any affected product along with the Advisory Acknowledgement and Stock Status Form. Arrow will either provide replacement with a similar product or credit customers' accounts. Customer Service can be contacted with questions or for clarification.

Device

Device Recall Percutaneous Sheath Introducer (PSI) Arrow Select Kit
  • Model / Serial
    Catalog number: ASK-09903-CMC, Lot number RF9060715
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MA.
  • Product Description
    Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605 || Permits venous access and catheter introduction 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