Recall Z-0354-2020 ยท NDC Calculator, Drug Dose
Monarch Medical Technologies
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
| Date | Oct 1, 2019 |
| Status | Terminated |
| Reason | Product was distributed prior to approval or clearance from FDA. |
| Root cause | Software change control |
| Action | 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. |
| Quantity | 6 units |
| Distribution | SC, IL IN, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.