Events

Recall of Device Recall EndoTool Drug Dose Calculator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira, 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
    56730
  • Event Risk Class
    Class 2
  • Event Number
    Z-0126-2011
  • Event Initiated Date
    2010-07-26
  • Event Date Posted
    2010-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94387
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Calibrators, ethyl alcohol - Product Code DNN
  • Reason
    The endotool software did not always provide an audible alert when a blood glucose measurement was due. this could result in a patient not receiving an appropriate dose of insulin.
  • Action
    Hospira issued an Urgent Device Field Correction letter dated July 23, 2010 to consignees, providing details of the potential issue and the associated patient risk. Hospira is finalizing software enhancements which will resolve this situation within the next 90 days ,and will contact each consignee when it is available to be downloaded from the Hospira website. The notification letter also included a clinical bulletin, outlining mitigation instructions for clinicians to use until the software enhancement is available. Consignees were requested to complete and return an attached Reply Form by fax. Customers can contact the Hospira EndoTool support line at 1-877-349-4582 for clinical inquiries about this recall.

Device

Device Recall EndoTool Drug Dose Calculator
  • Model / Serial
    Software Version 7.2.1800.3 and 7.2.1825.5
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution in states of CA, FL, IL, IN, KY, KS, MI, MO, MT, NC, NJ, NM, NV, OH, SC, SD, TN, TX, VA, WA, and WY.
  • Product Description
    EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
  • Manufacturer
    Hospira, Inc.

Manufacturer

Hospira, Inc.
  • Manufacturer Address
    Hospira, Inc., 600 N Field Dr Bldg J45, Lake Forest IL 60045
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA