FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for… — Class I medical device recall Z-1706-2015
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2015-06-17, distributed in AL, AZ, DC, FL, MI, MO, NJ, NY…. In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within
| Recall number | Z-1706-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2015-04-02 |
| Classified | 2015-06-08 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-07-06 |
| Distributed | AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, WV |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CH, CL, CN, CO, CZ, DE, EC, ES, FI, FR, GB, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LV, MX, NL, NO, OM, PA, PE, PL, PT, QA, RO, RS, RU, SA, SE, SG, SK, TH, TN, TR, TW, VE, ZA |
| Reason classes | packaging |
| Serial numbers | 1058, 1059, 1060, 1172, 1201, 1202, 1204, 1224, 1225, 1226, 1277, 1280, 1281, 1282, 1545, 1546, 1643, 1644, 1645, 1646, 1647, 1648, 1650, 1651, 1652 and 51 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1706-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.