Events

Recall of Sentry Pro Medication Safety Software

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
    44799
  • Event Risk Class
    Class 2
  • Event Number
    Z-0134-2008
  • Event Initiated Date
    2007-08-14
  • Event Date Posted
    2008-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64397
  • 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
    infusion pump programming software - Product Code FRN
  • Reason
    Incorrect dosage possible: a software anomaly in the cadd-sentry pro administrator software (version b) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if administrator displayed the values correctly at data entry.
  • Action
    A Smiths Medical MD employee visited the consignees between August 14 and 31, 2007, to verbally notify them of the recall, collect the recall CD-ROM containing the affected software and replace with the updated software.

Device

Sentry Pro Medication Safety Software
  • Model / Serial
    Catalog Number: 21-6275-51, Software Version B.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    UT, MD, CO
  • Product Description
    Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator || REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA
  • 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