Recall Z-1286-2024 ยท FRN Pump, Infusion
InfuTronix LLC
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
| Date | Mar 28, 2024 (initiated Feb 21, 2024) |
| Status | Open, Classified |
| Reason | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024. |
| Root cause | Device Design |
| Action | On February 21, 2024, the firm began notifying customers via URGENT MEDICAL DEVICE REMOVAL letters. Customers were informed that the identified Nimbus Infusion Pumps are being removed from the market. The products will no longer be supported by InfuTronix for the Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service at Customerservice@intuvie.com, where they will be instructed on the Return Material Authorization (RMA) process to |
| Quantity | 52,328 total |
| Distribution | Domestic US distribution nationwide. No international distribution. |
| FDA record | Open on fda.gov |