Z-1706-2015Class I

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia...

Name: Z-1706-2015 FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2015-04-02
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2015-04-02 / Terminated

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations on 2015-04-02. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1706-2015
Classification: Class I
Status: Terminated
Initiated: 2015-04-02
Posted: 2015-06-08
Terminated: 2016-07-06
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Product code: BSZ Gas-Machine, Anesthesia
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1706-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1706-2015	Class I	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08

Product code BSZ

K133958Class IIFlow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB / cleared 2014-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)