FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Reported: June 17, 2015 Initiated: April 2, 2015 #Z-1706-2015
Product Description
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Reason for Recall
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.
Details
- Recalling Firm
- Maquet Cardiovascular Us Sales, Llc
- Units Affected
- 1641 [80 units (US) 1561 units (OUS)]
- Distribution
- 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.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 1641 [80 units (US) 1561 units (OUS)].
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Critical. Recall number: Z-1706-2015.
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