EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

FDA device recall Z-0126-2011 · posted 2010-10-22 · Terminated

Recall details

Recalling firm

Hospira, Inc.

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.

Action taken

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

Status

Terminated

Product code

DNN

Quantity affected

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.

Date initiated

2010-07-26

Date posted

2010-10-22

Date terminated

2014-02-25

Location

Lake Forest, IL