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OxyPlus™

Southmedic Incorporated · Model OP-2325-8 · UDI-DI 10620974001031

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

Description

OxyPlus ETCO2, 7ft oxygen tubing, 8in sampling line with female connector ETTI

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.