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ToTXinCare
Tongxin Home Care Industry (Shenzhen) Co., Limited · Model TX-1026 · UDI-DI 06978579510029
10
510(k) clearances
827
Adverse events (21 deaths)
12
Recalls
144
Facilities
Description
A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-23 | Hollister Incorporated | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| 2024-12-23 | Hollister Incorporated | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| 2024-12-23 | Hollister Incorporated | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| 2024-12-23 | Hollister Incorporated | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| 2024-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh |
| 2024-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh |
| 2024-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh |
| 2024-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh |
| 2017-03-24 | Dale Medical Products, Inc. | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. |
| 2017-03-24 | Dale Medical Products, Inc. | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. |
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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.