EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
- Company
- Monarch Medical Technologies
- Recall Initiated
- October 1, 2019
- Recall Number
- Z-0354-2020
- Quantity
- 6 units
- Firm Location
- Charlotte, NC
Reason for Recall
Product was distributed prior to approval or clearance from FDA.
Distribution
SC, IL IN, CA
Lot / Code Info
versions: v 1.7.1, 1.7.4, 1.7.5
Root Cause
Software change control
Action Taken
The firm held meetings and emailed the consignees beginning on 09/27/2019 and followed with a letter. The notice stated that no medical decision should be based solely on the recommended guidance provided by the software program and requested the facility take additional precautions when following EndoTool SubQ dose recommendations.