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CRITIFLO(TM) TAK1712M

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 682129 · UDI-DI 00886333621293

DXO Prescription
10
510(k) clearances
2,433
Adverse events (21 deaths)
10
Recalls
60
Facilities

Description

60 drops, 60" tube AdSet packs with a Critiflo device connected to 3-Way OFF stopcock & a 12" Pressure Tubing. It also includes a separately packed 2x male protective caps and a colour label set.

Recalls

DateFirmReason
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2015-11-13Edwards Lifesciences, LLCEdward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devic
2015-07-31Edward Lifesciences, LlcFlow 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.