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Terminated

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

FDA Recall Z-1706-2015 · Posted 2015-06-08

Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeBSZ
Date Initiated2015-04-02
Date Terminated2016-07-06
Product Quantity1641 [80 units (US) 1561 units (OUS)]

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.

Firm Action

The firm, Maquet Inc., sent an "Urgent Medical Device Field Action Field Correction for FLOW-i Anesthesia Systems" letter dated 4/2/2015 via FedEx. The letter describes the product, problem and actions to be taken. The customers were instructed to read the letter and inform staff, who may use the FLOW-i Anesthesia System of the patient cassette locking device issue. Customers are to obtain the serial number of their system; verify the serial number obtained against the serial number listed in the box in the Appendix. A Maquet Service Representative will be contacting you to arrange a convenient time to replace your FLOW-i Anesthesia System patient cassette locking device. If you have any questions regarding this field action, please contact your Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (Press option 3, followed by option 1 and then option 1 again), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EST.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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