NA
Changsha Magill Medical Technology Co., Ltd. · Model EXT-1 · UDI-DI 06974599110508
10
510(k) clearances
466
Adverse events (9 deaths)
38
Recalls
164
Facilities
Description
This extension tube can be connected to breathing circuit independently or together with elbow connector when necessary.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.