| Subject: | Class I Recall of Edwards Lifesciences Aquarius Hemodialysis System |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 29 Jan 2010 - 10:00 am |
| Audience: Nephrology and hemodialysis healthcare professionals, hospital risk managers The Food and Drug Administration (FDA) and Edwards Lifesciences has notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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