Events

Recall of Device Recall Burette Set with SmartSite(TM) YInjection Site and SmartSite(TM) HEPLock on Burette SmartSite

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
    54723
  • Event Risk Class
    Class 1
  • Event Number
    Z-1130-2010
  • Event Initiated Date
    2010-02-01
  • Event Date Posted
    2010-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89602
  • 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
    Intravascular administration set - Product Code FPA
  • Reason
    Sterility may be compromised.
  • Action
    The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.

Device

Device Recall Burette Set with SmartSite(TM) YInjection Site and SmartSite(TM) HEPLock on Burett...
  • Model / Serial
    Product number MPI-17962.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom.
  • Product Description
    Burette Set with SmartSite(TM) Y-Injection Site and SmartSite(TM) HEP-Lock on Burette SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. || An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular 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