—#94387

Product

EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

FDA product code: DNN — Calibrators, Ethyl Alcohol
Device class: Class 2
Medical specialty: Clinical Toxicology
Affected lot / code info: Software Version 7.2.1800.3 and 7.2.1825.5

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Hospira, Inc.
Address: 600 N Field Dr, Bldg J45, Lake Forest, Illinois 60045

Distribution

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.

Timeline

Recall initiated: 2010-07-26
Posted by FDA: 2010-10-22
Terminated: 2014-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94387. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.