Recall Z-0126-2011 ยท DNN Calibrators, Ethyl Alcohol
Hospira, Inc.
EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
| Date | Oct 22, 2010 (initiated Jul 26, 2010) |
| Status | Terminated |
| 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. |
| 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 f |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.