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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2996-2026

Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D; 5) NEURO PACK, Medline Kit SKU DYNJ45121I; 6) NEURO LAMINECTOMY PACK, Medline Kit SKU DYNJ58012A; 7) NEURO PACK SJ, Medline Kit SKU DYNJ63477A; 8) BASIC NEURO PACK, Medline Kit SKU DYNJ83071A.

Publicado el 2 de septiembre de 2026 · Inicio del retiro: 8 de julio 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

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

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
US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
Lote
Medline Kit SKU CDS985246J, UDI/DI 10193489232394 (each) 40193489232395 (case), Lot Number 22HMB295; Medline Kit SKU CDS985246J, UDI/DI 10193489232394 (each) 40193489232395 (case), Lot Number 22IMB860; Medline Kit SKU DYNJ32770V, UDI/DI 10195327090111 (each) 40195327090112 (case), Lot Number 22FMB806; Medline Kit SKU DYNJ40095D, UDI/DI 10195327281250 (each) 40195327281251 (case), Lot Number 23GMI744; Medline Kit SKU DYNJ42844D, UDI/DI 10193489880564 (each) 40193489880565 (case), Lot Number 25EBV362; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25CMH980; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25FMB096; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25GMA066; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25GMH940; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25BMI081; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25IMC735; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24DME519; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24EMG256; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24GMJ491; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24IMA243; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24JMA162; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24JMD784; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24KMI470; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24ABN077; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24ABN475; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24DBA116; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23AMH395; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23EMA407; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBH164; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBO192; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBV863; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23IBF802; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23IBS028; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23JBV613; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22BME230; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22CMA406; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22EMB248; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22EMI134; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22HME564; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22IMA455; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22JMI068; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22LMB601; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 24BMI624; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 24EME751; Medline Kit SKU DYNJ58
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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