FDA recall Z-0354-2020
Monarch Medical Technologies · Class II · device
Product
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
SC, IL IN, CA
Key facts
- Status
- Terminated
- Initiation date
- 2019-10-01
- Report date
- 2019-11-20
- Termination date
- 2026-02-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Charlotte, NC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0354-2020