FDAFDA · Alimentos y medicamentos·N.º oficial Z-2033-2026
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
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 CDS780056K: UDI/DI each 10888277941373, UDI/DI case 40888277941374, Lot Number: 21DBU610; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21KBG946; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21IBV394; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23IBO480; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23FBL915; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23EBP966; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23DBB223; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23CBO553; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23ABG956; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22KBD840; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22IBK666; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22HBZ276; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22GBK671; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22FBI951; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22EBE862; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22OBA987; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22BBC815; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21KBC808; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21HBM967; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21FBD640; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBN004; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBB965; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBU070; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBS617; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABT989; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABR939; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABE858; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBU114; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBB359; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBA010; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBP286; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBI821; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26BBJ914; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26ABU117; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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