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Terminated

EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

FDA Recall Z-0126-2011 · Posted 2010-10-22

Recalling FirmHospira, Inc.
Recall StatusTerminated
Product CodeDNN
Date Initiated2010-07-26
Date Terminated2014-02-25
Product Quantity97 units total (96 version 7.2.1800.3 and 1 version 7.2.1825.5)

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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