Z-0126-2011

EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

Name: Z-0126-2011 EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
Creator: Hospira, Inc.
Published: 2010-07-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-07-26 / Terminated / root cause: software

FDA source

Hospira, Inc. began a recall of EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5 on 2010-07-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0126-2011
Status: Terminated
Initiated: 2010-07-26
Posted: 2010-10-22
Terminated: 2014-02-25
Recalling firm: Abbott Medical
Product: EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
Product code: DNN Calibrators, Ethyl Alcohol
Reason for recall: 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.
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 97 units total (96 version 7.2.1800.3 and 1 version 7.2.1825.5)
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 codes and lots: Software Version 7.2.1800.3 and 7.2.1825.5

Product code DNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)