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HUDSON RCI

TELEFLEX INCORPORATED · Model IPN913731 · UDI-DI 34026704659372

OGG Prescription
0
510(k) clearances
723
Adverse events (3 deaths)
2
Recalls
31
Facilities

Description

COMFORT FLO

Recalls

DateFirmReason
2026-07-13Medline Industries, LPNeonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,
2014-09-03Teleflex MedicalPossibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.

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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.