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Curaplex
BOUND TREE MEDICAL, LLC · Model 023060S · UDI-DI 00815277020008
1
510(k) clearances
39
Adverse events (3 deaths)
3
Recalls
2
Facilities
Description
Curaplex Intubation Kit Nasal With 6.0mm Endotracheal Tube
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-12 | Sarnova HC, Llc | Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endo |
| 2024-02-12 | Sarnova HC, Llc | Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endo |
| 2006-09-27 | Teleflex Medical | Biological indicator failed. Investigation eliminated all equipment and product related factors. |
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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.