FDAFDA · Alimentos y medicamentos·N.º oficial Z-2988-2024
Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
Publicado el 18 de septiembre de 2024 · Inicio del retiro: 8 de abril de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- MEDLINE INDUSTRIES, LP - Northfield
- Distribuidor
- Worldwide distribution.
- Lote
- DYNJRA0377B, Lot Number 19DDB791 ; DYNJRA0377B, Lot Number 21KDA359 ; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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