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POM Elite MM
STRYKER CORPORATION · Model 1001-MM · UDI-DI 10851438008024
CCK
Prescription
10
510(k) clearances
12,829
Adverse events (34 deaths)
84
Recalls
221
Facilities
Description
Adult Procedural Oxygen Mask with High and Medium Concentration and CO2 Monitoring (Male to Male)
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.