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Maquet Cardiovascular Us Sales, Llc recalls FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neon
Recalled June 17, 2015 · FDA recall Z-1706-2015 · Maquet Cardiovascular Us Sales
Hazard
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. · FDA Class I
Units
1641 [80 units (US) 1561 units (OUS)]
Sold at
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, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Libya, Mexico, Mongolia, Mozambique, Netherlands, Norway Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Unites States, and Venezuela.
Description
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.
Product
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Manufacturer(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →