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Pediatric EtCO2 Nasal Sample Line

SALTER LABS · Model SO-1651 · UDI-DI 00607411201516

CCK Prescription
1
510(k) clearances
12,829
Adverse events (34 deaths)
84
Recalls
221
Facilities

Description

Pediatric EtCO2 Nasal Sample Line with 7’ (2.1 m) supply tube, female connector (Philips Reorder Number 989803152571)

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.