Recall Z-0354-2020
Monarch Medical Technologies · initiated October 1, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Codes / lots: versions: v 1.7.1, 1.7.4, 1.7.5
Reason for recall
Product was distributed prior to approval or clearance from FDA.
FDA-determined 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.
Details
- Recall number
- Z-0354-2020
- Initiated
- October 1, 2019
- Terminated
- February 10, 2026
- Product code
- NDC – Calculator, Drug Dose
- Quantity
- 6 units
- Distribution
- SC, IL IN, CA
- Recalling firm
- Monarch Medical Technologies, Charlotte, NC