On December 11, 2024, Nuwellis Sent A Notice To Affected Customers That It Is Voluntarily Recalling Specific Lots Of AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit Which Is Used With The Aquadex Smartflow Or Aquadex Flexflow System - Filing
On December 11, 2024, Nuwellis Sent A Notice To Affected Customers That It Is Voluntarily Recalling Specific Lots Of AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit Which Is Used With The Aquadex Smartflow Or Aquadex Flexflow System - Filing
The lots are being recalled due to failures of the blood circuit associated with too many mismatch alarms. The blood circuits 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.
這些批次之所以被召回，是因爲與過多的不匹配警報器相關的血液迴路故障。使用時，血液迴路可能顯示 「超濾液重量不匹配」 或 「超重不匹配」 警報。如果不加以解決，這種失敗可能導致患者體內多餘的液體排出，導致急性容量耗竭。
As of the date of this Current Report on Form 8-K, the Company is aware of five reported incidences of blood circuit product failures, with three leading to patient dehydration and requiring administration of fluids.
截至本表8-k最新報告發布之日，公司已報告了五起血液迴路產品故障事件，其中三起導致患者脫水並需要注射液體。
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration which has not yet characterized the Class of the recall.
此次召回是在美國食品藥品監督管理局知情的情況下進行的，該局尚未確定召回的類別。
