Recall Z-0832-2022 ยท FRN Pump, Infusion
InfuTronix LLC
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
| Date | Oct 19, 2021 |
| Status | Open, Classified |
| Reason | An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients. |
| Root cause | Employee error |
| Action | An IMPORTANT PRODUCT INFORMATION letter dated 10/19/21 was sent to customers. InfuTronix LLC has recently become aware of an unreleased Version 4 Protocol Library for Duke University Hospital was installed on your Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients. Please ensure that all your potential customers and potential users in your facility are made aware of this notification and the recommended actions. Product Issue Version 4 of the Duke Protocol Library was installed on your infusion pumps in error. Affected Product Details Nimbus PainPr |
| Quantity | 74 units |
| Distribution | US Nationwide distribution in the states of NC and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion Zyno Medical, LLC, Aug 30, 2016 |