Events

Recall of Device Recall Deltec 3000 Large Volume Infusion Pump,

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
    47482
  • Event Risk Class
    Class 2
  • Event Number
    Z-1604-2008
  • Event Initiated Date
    2008-02-27
  • Event Date Posted
    2008-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69558
  • 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
    Large Volume Infusion Pump - Product Code FRN
  • Reason
    The deltec, graseby, and 3m, large volume infusion pump - models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. this problem is due to a timing delay when the pumping mechanism resets itself.
  • Action
    A Smiths Medical "Urgent Medical Device Correction" letter dated 2/5/08 was sent to consignees on 2/27/08. The letter was addressed to Risk/Safety Managers, Clinicians, Nursing Staff and other users of the above products. The letter also included Details on affected devices, Description of the problem , Advice on action to be taken by the user, Warning and requested the return the confirmation form. Contact Smiths Medical at 1-800-426-2448 for assistance. Please note: The 3M was the original brand for the large volume infusion pump models 3000 and 3100 marketed in the USA from 1994 through 1997. The Graseby large volume infusion pump models 3000 and 3100 were marketed from 1997 through 1999. Since 1999, the current marketed brand is the Deltec models 3000 and 3100. Smith Medical MD, Inc., included the 3M and Graseby brand large volume infusion pumps in the product field safety notice in the event these brands of infusion pumps are still in use.

Device

Device Recall Deltec 3000 Large Volume Infusion Pump,
  • Model / Serial
    All serial numbered devices affected.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AR, AZ, CA, CO, CT, DC, FL. GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, ,MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK OR,PA, RI,SC, TN, TX, UT,VA, VT, WA, WI, WV, and WY
  • Product Description
    Deltec¿ 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK. || Reorder numbers 21-5301-01 & 21-5306-01 || The product is used for general drug delivery infusion therapies. The product is only intended to be used by trained clinicians.
  • 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