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Airway Adapters
Respironics Novametrix, LLC · Model 1149448 · UDI-DI 00884838104792
BZA
Prescription
10
510(k) clearances
466
Adverse events (9 deaths)
38
Recalls
164
Facilities
Description
Neonatal/Pediatric Airway Adapter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-10 | Draeger, Inc. | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| 2025-11-10 | Draeger, Inc. | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| 2025-11-10 | Draeger, Inc. | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| 2025-11-10 | Draeger, Inc. | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| 2024-09-27 | Westmed, Inc. | Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause |
| 2024-07-18 | Smiths Medical ASD Inc. | Uncertainty in the seal integrity of the sterile packaging. |
| 2023-04-05 | Smiths Medical ASD Inc. | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning me |
| 2023-04-05 | Smiths Medical ASD Inc. | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning me |
| 2023-04-05 | Smiths Medical ASD Inc. | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning me |
| 2019-08-15 | Bioseal Corporation | The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation n |
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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.