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CRITIFLO(TM) TAK1760M

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 682128 · UDI-DI 00886333621286

DXO Prescription

510(k) clearances

2,433

Adverse events (21 deaths)

Recalls

Facilities

Description

A separate 60 drops,60" tube Adset and a Critiflo flushing device connected to a 3-Way White OFF stopcock, Pressure tubing of length 48", 3-Way White OFF stopcock and 12" Pressure tubing. It also includes a separately packed 2x male protective caps.

Recalls

Date	Firm	Reason
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2015-11-13	Edwards Lifesciences, LLC	Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devi
2015-07-31	Edward Lifesciences, Llc	Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the sys

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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.