Recall Z-1811-2024 ยท FRN Pump, Infusion
OptumHealth Care Solutions LLC
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
| Date | May 21, 2024 (initiated Apr 18, 2024) |
| Status | Open, Classified |
| Reason | Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the 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. |
| Root cause | Device Design |
| Action | Optumhealth Care Solutions, LLC issued an Urgent Device Recall by the Manufacturer of Nimbus II Pump notice to its consignees on 04/18/2024 via email Delivery/Adobe Sign and UPS Next Day Air. The notice sent an electronic link to the press release and stated that a nurse would be contacting the consignee to schedule a pump replacement, including a home visit to instruct the patient on the use of the new pump. In the meantime, if you have any issue with your current Nimbus II pump, please contact your nurse right away to prioritize your pump replacement. Additionally, the manufacturer recomm |
| Quantity | 208 units |
| Distribution | US Nationwide Distribution |
| 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 |