Company: Monarch Medical Technologies
Date of Enforcement Report: 6/26/2019
Class II
PRODUCT
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Recall Number: Z-1786-2019
REASON
Insulin dosing calculations were erroneously high.
RECALLING FIRM/MANUFACTURER
Monarch Medical Technologies on 5/3/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
83 downloads
DISTRIBUTION
US Nationwide and Dubai