Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study

BACKGROUND: Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be identified, assessed, and corrected or removed, upon which a recal...

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Detalles Bibliográficos
Autores principales: Mooghali, Maryam, Ross, Joseph S, Kadakia, Kushal T, Dhruva, Sanket S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2023
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10204764/
https://www.ncbi.nlm.nih.gov/pubmed/37229515
http://dx.doi.org/10.2147/MDER.S412802

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10204764/
https://www.ncbi.nlm.nih.gov/pubmed/37229515
http://dx.doi.org/10.2147/MDER.S412802

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