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OSSEOUS- NeckFit Tube Holder
EON MEDITECH PRIVATE LIMITED · Model EA91053 · UDI-DI 08904428744947
CBH
Prescription
10
510(k) clearances
822
Adverse events (21 deaths)
12
Recalls
144
Facilities
Description
Made with soft foam and comfort fabric. Can be easily attached to the rib of laryngectomy tube or button. Dual-piece special design to facilitate adjustment of required size, whereas Velcro ensures for ideal adhesion grip.
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.