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U.S. Department of Health and Human Services

Class 2 Device Recall Monarch Medical Technologies EndoTool IV

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  Class 2 Device Recall Monarch Medical Technologies EndoTool IV see related information
Date Initiated by Firm May 03, 2019
Create Date June 15, 2019
Recall Status1 Open3, Classified
Recall Number Z-1786-2019
Recall Event ID 82828
510(K)Number K132547  
Product Classification Calculator, drug dose - Product Code NDC
Product Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Code Information Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
Recalling Firm/
Manufacturer		 Monarch Medical Technologies
2137 South Blvd Ste 300
Charlotte NC 28203-5189
For Additional Information Contact Bruce Lisanti
855-363-7475
Manufacturer Reason
for Recall		 Insulin dosing calculations were erroneously high.
FDA Determined
Cause 2		 Software change control
Action The firm notified the consignees by email beginning on 05/03/2019. The notice alerted the consignee of the problem and provided an educational brief and a tip card to provide to the staff to remind them to always use clinical judgement in following EndoTool IV dose recommendations.
Quantity in Commerce 83 downloads
Distribution Nationwide and Dubai
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NDC and Original Applicant = MONARCH MEDICAL TECHNOLOGIES
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