Class 2 Device Recall EndoTool SubQ

• Date Initiated by Firm: October 01, 2019
• Create Date: November 08, 2019
• Recall Status: Open, 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/ Manufacturer: Monarch Medical Technologies; 2137 South Blvd Ste 300; Charlotte NC 28203-5189
• For Additional Information Contact: Bruce Lisante; 855-363-7475
• Manufacturer Reason for Recall: Product was distributed prior to approval or clearance from FDA.
• FDA Determined Cause: 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.