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1-Slot CO2/O2 Module
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Model 115-056531-00 · UDI-DI 06936415919061
CCK
Prescription
1
510(k) clearances
12,829
Adverse events (34 deaths)
84
Recalls
221
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-07 | Philips North America Llc | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. |
| 2025-02-17 | Oridion 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 |
| 2025-02-17 | Oridion 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 |
| 2025-02-17 | Oridion 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 |
| 2025-02-17 | Oridion 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 |
| 2025-02-17 | Oridion 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 |
| 2025-02-17 | Oridion 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 |
| 2025-02-17 | Oridion 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 |
| 2025-02-17 | Oridion 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 |
| 2025-02-17 | Oridion 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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Get your free API keyRead the docsData 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.