Events

Recall of Device Recall Primary Administration Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical MD, 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
    30603
  • Event Risk Class
    Class 2
  • Event Number
    Z-0487-05
  • Event Initiated Date
    2004-12-03
  • Event Date Posted
    2005-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36437
  • 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
    Set, Administration, Intravascular - Product Code FPA
  • Reason
    Administration sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate.
  • Action
    Customers were sent a product Safety & Recall notification via email or regular mail begining 12/03/04 through 12/08/04. A Product Recall form requested the customer for feedback as to Quantity Used, Quantity to be Retained and Quantity to be returned . The Customer Recall Notication states that if no Administration Sets from alternative lots are available and the use of the volumetric pump is essential, follow the instructions in the attached Customer Information Bulletin, which describes how to identify a set which does not have the defect. Customers who find product subject to the recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths.

Device

Device Recall Primary Administration Set
  • Model / Serial
    FEB04T02, FEB04T03, FEB04T04, FEB04T12, FEB04T19, FEB04T20, FEB04T21, FEB04T35, FEB04T36, FEB0437, MAR04T01, MAR04T10, MAR04T11, MAR04T18, MAR04T25, MAR04T27, MAR04T28, MAR04T32, MAR04T33, MAR04T35, MAR04T36, APR04T01, APR04T11, APR04T12, APRT0415, APR04T21, APR04T25 & APR04T26 distributed Internationally.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    worldwide.
  • Product Description
    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C820 (Reorder No. 21-0346-25) Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Injection site.
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Manufacturer Address
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA