Nuwellis voluntarily recalls AquaFlexFlow UF 500 Plus blood circuits over mismatch alarms

Nuwellis, Inc.

Recall of specific lots due to 'Ultrafiltrate Weight Mismatch' alarms; may cause excess fluid removal leading to acute volume depletion.
Five reported incidences of product failures; three caused patient dehydration requiring fluid administration.
Recall conducted with FDA knowledge; FDA has not yet classified recall class.
Affected product: AquaFlexFlow UF 500 Plus blood circuit used with Aquadex Smartflow or FlexFlow systems.

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