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DOSI-FLOW

LEVENTON SAU · Model L259000050 · UDI-DI 08436020760099

LDR Prescription
1
510(k) clearances
73
Adverse events
5
Recalls
6
Facilities

Description

I.V. Extension Set with Flow Regulator

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 investigation of the complain
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 investigation of the complain
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 incorrect component which co
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.