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Attachment, Breathing, Positive End Expiratory Pressure
FDA product code BYE · Class 2 · Anesthesiology
783
Registered devices
255
Adverse events
11
Recalls
80
510(k) clearances
Devices with this code
Whisperflow CPAP Valve — Respironics Novametrix, LLCCuraplex — BOUND TREE MEDICAL, LLCN/A — GALEMED CORPORATIONRescuer Emergency CPAP System — B.L.S. Systems LimitedInfant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITEDO2-MAX — PULMODYNE INCO2-MAX — PULMODYNE INCSunmed — SUNMED, LLC02-RESQ — PULMODYNE INC02-MAX — PULMODYNE INCEmergent Respiratory — MDL Solutions IncorporatedShiley — Covidien LP02-MAX — PULMODYNE INCWhisperflow CPAP Valve — Respironics Novametrix, LLC02-RESQ — PULMODYNE INCN/A — GALEMED CORPORATIONFlow-Safe II Disposable CPAP System — MERCURY ENTERPRISES, INC.Whisperflow CPAP Valve — Respironics Novametrix, LLC02-MAX — PULMODYNE INCO2-MAX — PULMODYNE INCVYGON — VYGONPEEP VALVE 10cmH2O;STRAIGHT CONNECTORS 30m,22m — BESMED HEALTH BUSINESS CORP.AincA — ANESTHESIA ASSOCIATES, INC.Rescuer Emergency CPAP System — B.L.S. Systems Limited
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-03 | Draeger, Inc. | Potential cracks in the hose, which could lead to leakage or the hose falling off. |
| 2019-01-15 | Westmed, Inc. | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted |
| 2019-01-15 | Westmed, Inc. | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted |
| 2019-01-15 | Westmed, Inc. | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted |
| 2015-09-24 | Airways Development LLC | Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determin |
| 2008-03-04 | Smiths Medical ASD, Inc. | Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive |
| 2008-03-04 | Smiths Medical ASD, Inc. | Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive |
| 2007-08-21 | Ambu Incorporated | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. |
| 2007-08-21 | Ambu Incorporated | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. |
| 2007-08-21 | Ambu Incorporated | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. |
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