Events

Recall of Device Recall Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer Set

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
    57572
  • Event Risk Class
    Class 2
  • Event Number
    Z-0936-2011
  • Event Initiated Date
    2010-12-20
  • Event Date Posted
    2011-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96674
  • 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
    Packaging may have been compromised, and sterility of product cannot be guaranteed.
  • Action
    The firm, Teleflex Medical thru its subsidiary Arrow International, Inc., sent an "Urgent Field Safety Notice" letter dated December 20, 2010, with Field Acknowledgement form to all customers. The letter described the product, problem and action to be taken by the customers. The letter instructed the customers to check their stock for affected product, cease use and distribution of product and quarantine all products from affected lot immediately; contact their local Teleflex Medical Customer Service/Sales Rep (or Distributor) for a return authorization number prior to filling out the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM; and complete and return the form immediately by email. If you do not have the product from the affected lot, indicate it on the form and fax it to your local Teleflex Medical Customer Service/Sales Rep (or Distributor). The Teleflex Medical Customer Service/Sales Rep (or Distributor) will coordinate the product return with the customer. If you have any questions, please contact the Regulatory Affairs Project Manager at 610-378-0131 ext 3318 or email: Jody.Cadd@teleflexmedical.com.

Device

Device Recall Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer Set
  • Model / Serial
    Part No: CL-07645, Lot No: CF0014630
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International distribution only: countries include: Austria, Belgium, Czech Republic, Germany, Greece, Italy, and Luxembourg.
  • Product Description
    Super Arrow-Flex(R) PSI Set || Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures
  • 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