Maquet Cardiovascular Us Sales, Llc recalls FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonat…

Recall date

April 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1706-2015

FDA classification

Class I

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, Hunga…

Why it was recalled

In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.