FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
This recall has been terminated (originally issued June 8, 2015).
- Recall Initiated
- April 2, 2015
- Posted
- June 8, 2015
- Terminated
- July 6, 2016
- Recall Number
- Z-1706-2015
- Quantity
- 1641 [80 units (US) 1561 units (OUS)]
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Article number 66 77 200 66 77 300 66 77 400 Serial Numbers 1058 1646 2034 2723 1059 1647 2095 2724 1060 1648 2186 2729 1172 1650 2554 2731 1201 1651 2555 2732 1202 1652 2556 2733 1204 1653 2557 2735 1224 1654 2558 2736 1225 1655 2559 2737 1226 1656 2560 2738 1277 1657 2561 2739 1280 1786 2562 2740 1281 1787 2613 2741 1282 1860 2714 2742 1545 1861 2716 2743 1546 2021 2719 2744 1643 2022 2720 2745 1644 2023 2721 2746 1645 2024 2722 2747
Root Cause
Under Investigation by firm
Action Taken
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.