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U.S. Department of Health and Human Services

Class 2 Device Recall EndoTool Drug Dose Calculator

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 Class 2 Device Recall EndoTool Drug Dose Calculatorsee related information
Date Initiated by FirmJuly 26, 2010
Date PostedOctober 22, 2010
Recall Status1 Terminated 3 on February 25, 2014
Recall NumberZ-0126-2011
Recall Event ID 56730
Product Classification Calibrators, ethyl alcohol - Product Code DNN
ProductEndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
Code Information Software Version 7.2.1800.3 and 7.2.1825.5
FEI Number 3013319212
Recalling Firm/
Manufacturer		 Hospira, Inc.
600 N Field Dr Bldg J45
Lake Forest IL 60045
For Additional Information ContactIleana Quinones
224-212-4892
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionHospira 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 Commerce97 units total (96 version 7.2.1800.3 and 1 version 7.2.1825.5)
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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