BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1706-2015 · Initiated April 2, 2015

    Recall

    Recall Number
    Z-1706-2015
    Event Number
    71054
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 2, 2015
    Posted
    June 8, 2015
    Terminated
    July 6, 2016
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

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

    Reason

    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.

    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.

    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.

    Quantity

    1641 [80 units (US) 1561 units (OUS)]