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AirLife™

SUNMED, LLC · Model 0930 · UDI-DI 10889483230367

CCK Prescription
10
510(k) clearances
12,829
Adverse events (34 deaths)
84
Recalls
221
Facilities

Description

AirLife™ CO2/O2 Mask, Adult Elongated CO2/O2 Mask, 7' Tubing with Thread Nut, Swivel GSE, 10' GSE X .038" ID X .107" OD, Reflective Luer Connectors

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.