FDAFDA · Alimentos y medicamentos·N.º oficial Z-2025-2026
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
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 CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23KBN711; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23GBD593; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23GBD781; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23DBF906; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22LBI985; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22KBC504; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22IBF741; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22FBX069; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22DBS948; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22CBX667; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 21IBT137; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 21HBG608; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 25GBV215; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 25GBA852; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24KBJ988; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24JBC528; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24IBV131; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24IBP386; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24GBA976; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24CBU492; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23KBW165; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 26ABK337; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 25JBE079; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 25HBV443; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25IBR604; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25HBR025; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25GBB389; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25FBC324; Medline Kit Number/SKU CDS983100D: UDI/DI each 10198459007934, UDI/DI case 40198459007935, Lot Number: 24KBH657; Medline Kit Number/SKU CDS983100D: UDI/DI each 10198459007934, UDI/DI case 40198459007935, Lot Number: 24GBN523; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23IBT936; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23HBA798; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23FBF767; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23DBD282; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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