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HomeIntersurgical Incorporated › SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE

SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE

Intersurgical Incorporated · Model 1143017 · UDI-DI 05030267157686

CCK Prescription
10
510(k) clearances
12,717
Adverse events (34 deaths)
84
Recalls
221
Facilities

Description

SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE FOR M/S CAPNOGRAPHY, FILTER AND TUBE, 2.1M

Recalls

DateFirmReason
2025-04-07Philips North America LlcDisconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc
2025-02-17Oridion Medical 1987 Ltd.Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disc

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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.