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HomeBluePoint Medical GmbH & Co. KG › GE Healthcare Airway Gas Sampling Set

GE Healthcare Airway Gas Sampling Set

BluePoint Medical GmbH & Co. KG · Model Adult/Pediatric, 2m/7ft · UDI-DI 24251679601511

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

Description

Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.

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.