FDA Device Intelligence
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Controller, Infusion, Intravascular, Electronic

FDA product code LDR · Class 2 · General Hospital

5
Registered devices
73
Adverse events
5
Recalls
60
510(k) clearances

Devices with this code

DOSI-FLOW — LEVENTON SAUDOSI-FLOW — LEVENTON SAUDOSI-FLOW — LEVENTON SAUIradimed — IRADIMED CORP.DOSI-FLOW — LEVENTON SAU

Recent recalls

DateFirmReason
2017-06-19ConMed CorporationIntravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
2011-04-15ConMed CorporationConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investiga
2011-04-15ConMed CorporationConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investiga
2011-04-15ConMed CorporationConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrec
2011-03-11Leventon S. A. U.Leventon, S.A.U. Barcelona, Spain is recalling DOSI-FLOW REGULATOR, Part Number 259-0250, Lot Numbers 101444L and 101494L. Product has potential to leak.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.