FDAFDA · Alimentos y medicamentos·N.º oficial Z-2021-2026
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
Publicado el 6 de mayo de 2026 · Inicio del retiro: 19 de marzo de 2026
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
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
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
- Distribuidor
- Worldwide distribution.
- Lote
- Medline Kit Number/SKU AM310B: UDI/DI each 10193489242126, UDI/DI case 40193489242127, Lot Number: 20XBG776; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23JBF547; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23GBK604; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBO915; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBD581; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABP476; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABD648; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22LBE888; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBL188; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBF976; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22FBN678; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22DBK641; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22BBU367; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22ABD373; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21JBC146; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21IBA072; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBN768; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBB075; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21EBI490; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24CBU365; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24BBE020; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24ABJ712; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23LBM852; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 26BBM084; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25LBS053; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25KBL217; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25JBA568; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25GBM602; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25FBB309; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBN201; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBI539; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24KBJ971; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBV278; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBR437; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lo
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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