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Open, Classified

Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

FDA Recall Z-1786-2019 · Posted None

Recalling FirmMonarch Medical Technologies
Recall StatusOpen, Classified
Product CodeNDC
Date Initiated2019-05-03
Product Quantity83 downloads

Reason for Recall

Insulin dosing calculations were erroneously high.

Firm 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.

Root Cause

Software change control

Distribution Pattern

Nationwide and Dubai

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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