Recall Z-0831-2025 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Nuwellis Inc
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
| Date | Jan 16, 2025 (initiated Dec 11, 2024) |
| Status | Completed |
| Reason | The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients. |
| Root cause | Under Investigation by firm |
| Action | Nuwellis issued an UREGNT: MEDICAL DEVICE RECALL notice to its consignees on 12/11/2024 via email. The notice explained the issue, risk to health, and requested the following actions be taken: Immediately discontinue use of affected lots. A Nuwellis representative will be reaching out to arrange return or disposal of the affected product to Nuwellis. For more detailed discussion regarding this product return, you may contact the Quality Team at Nuwellis: Steve Sandoval, Director of Engineering and Quality, Email: Steve.Sandoval@nuwellis.com, Office Phone: +1 952.563.7040 |
| Quantity | 845 units |
| Distribution | US Nationwide Distribution and the country of Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192756 | Aquadex FlexFlow System 2.0 Chf Solutions, Inc., Feb 24, 2020 |