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U.S. Department of Health and Human Services

Class 2 Device Recall EndoTool SubQ

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  Class 2 Device Recall EndoTool SubQ see related information
Date Initiated by Firm October 01, 2019
Create Date November 08, 2019
Recall Status1 Open3, Classified
Recall Number Z-0354-2020
Recall Event ID 83926
Product Classification Calculator, drug dose - Product Code NDC
Product EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Code Information versions: v 1.7.1, 1.7.4, 1.7.5
Recalling Firm/
Monarch Medical Technologies
2137 South Blvd Ste 300
Charlotte NC 28203-5189
For Additional Information Contact Bruce Lisante
Manufacturer Reason
for Recall
Product was distributed prior to approval or clearance from FDA.
FDA Determined
Cause 2
Software change control
Action The firm held meetings and emailed the consignees beginning on 09/27/2019 and followed with a letter. The notice stated that no medical decision should be based solely on the recommended guidance provided by the software program and requested the facility take additional precautions when following EndoTool SubQ dose recommendations.
Quantity in Commerce 6 units
Distribution SC, IL IN, CA
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.