Home / Recalls / Monarch Medical Technologies / Z-0354-2020

Z-0354-2020 Class II Terminated

Recalled by Monarch Medical Technologies — Charlotte, NC

Recall Details

Product Type: Devices
Report Date: November 20, 2019
Initiation Date: October 1, 2019
Termination Date: February 10, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 units

Product Description

EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

Reason for Recall

Product was distributed prior to approval or clearance from FDA.

Distribution Pattern

SC, IL IN, CA

Code Information

versions: v 1.7.1, 1.7.4, 1.7.5