FDA recall Z-1786-2019
Monarch Medical Technologies · Class II · device
Product
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Reason for recall
Insulin dosing calculations were erroneously high.
Distribution
Nationwide and Dubai
Key facts
- Status
- Ongoing
- Initiation date
- 2019-05-03
- Report date
- 2019-06-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Charlotte, NC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1786-2019