Reported Jan 22, 2025 · Completed
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with…
Nuwellis Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nuwellis Inc · 12988 Valley View Rd · Eden Prairie, MN · 55344-3657
Is this the product you have?
- nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
- Lot codes and dates
- Lot Numbers
226972269822699227002270122702227032270422705227062270722708227212272222723227242273322734227352273622737227382273922740
- Lot Numbers
- Amount recalled
- 845 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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