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U.S. Department of Health and Human Services

Class 1 Device Recall AquaFlexFlow UF 500 Plus

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 Class 1 Device Recall AquaFlexFlow UF 500 Plussee related information
Date Initiated by FirmDecember 11, 2024
Date PostedJanuary 16, 2025
Recall Status1 Completed
Recall NumberZ-0831-2025
Recall Event ID 95991
510(K)NumberK192756 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Productnuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Code Information Lot Numbers: 22697, 22698, 22699, 22700, 22701, 22702, 22703, 22704, 22705, 22706, 22707, 22708, 22721, 22722, 22723, 22724, 22733, 22734, 22735, 22736, 22737, 22738, 22739, 22740.
Recalling Firm/
Manufacturer		 Nuwellis Inc
12988 Valley View Rd
Eden Prairie MN 55344-3657
For Additional Information ContactNestor Jaramillo, Jr.
952-345-4204
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionNuwellis 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 in Commerce845 units
DistributionUS Nationwide Distribution and the country of Hong Kong
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = KDI
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