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Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in)
SUNSET HEALTHCARE SOLUTIONS, INC. · Model RES030P-10 · UDI-DI 00848530103545
10
510(k) clearances
822
Adverse events (21 deaths)
12
Recalls
144
Facilities
Description
Pediatric Two Piece Trach Ties, 2x25.5cm (10in) - 20/box
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.