Recall Z-1786-2019— Monarch Medical Technologies

Name: FDA recall Z-1786-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-03

Class II · Ongoing

Class II FDA medical device recall by Monarch Medical Technologies, initiated 2019-05-03. It names one FDA 510(k) clearance: K132547. Product: Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.. Reason: Insulin dosing calculations were erroneously high..

Recalling firm: Monarch Medical Technologies
Classification: Class II
Status: Ongoing
Initiated: 2019-05-03
Firm location: Charlotte, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K132547 — ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)Monarch Medical Technologies·cleared 2014-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.