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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2107-2026

Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) NEURO/LAMINECTOMY BASIN PK-LF, Model Number: DYNJ0781823K; 15) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 16) NEURO PACK, Model Number: DYNJ49098I; 17) NEURO PACK, Model Number: DYNJ53089B; 18) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 19) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 20) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 21) NEURO PACK, Model Number: DYNJ60792B; 22) NEURO PACK, Model Number: DYNJ60792C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 24) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 25) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157F; 26) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 27) NEURO PACK, Model Number: DYNJ61740D; 28) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 29) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 30) DISCECTOMY PACK, Model Number: DYNJ67835; 31) FSC NEURO PACK, Model Number: DYNJ80442B; 32) WWD NEURO PACK, Model Number: DYNJ80849B; 33) WWD NEURO PACK, Model Number: DYNJ80849C; 34) WWD NEURO PACK, Model Number: DYNJ80849D; 35) WWD NEURO PACK, Model Number: DYNJ80849F; 36) WWD NEURO PACK, Model Number: DYNJ80849G; 37) WWD NEURO PACK, Model Number: DYNJ80849I; 38) WWD NEURO PACK, Model Number: DYNJ80849J; 39) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 40) NEURO, Model Number: DYNJ900904J; 41) NEURO, Model Number: DYNJ900904K; 42) NEURO, Model Number: DYNJ900904L; 43) NEURO, Model Number: DYNJ900904M; 44) NEURO, Model Number: DYNJ902585; 45) NEURO, Model Number: DYNJ902585A; 46) NEURO - IFCAP 230316, Model Number: DYNJ908393; 47) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 48) NEURO - IFCAP 230316, Model Number: DYNJ908393B; 49) NEURO KIT, Model Number: DYNJ909573; 50) NEURO, Model Number: DYNJ910384; 51) NEURO, Model Number: DYNJ910384A; 52) NEURO PACK-LF, Model Number: PHS390015M

Publicado el 13 de mayo de 2026 · Inicio del retiro: 7 de enero 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

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medline Industries, LP
Distribuidor
Worldwide - US Nationwide distribution.
Lote
1) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21CBA213; 2) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21DBD719; 3) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMA403; 4) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GME436; 5) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMF497; 6) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21JMH357; 7) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21KMD971; 8) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21LMG598; 9) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22DMD555; 10) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22HMC764; 11) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22KMF991; 12) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23AMJ086; 13) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMD444; 14) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMH970; 15) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23EME270; 16) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23GMC110; 17) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23IME897; 18) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMA572; 19) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMI786; 20) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23KMB758; 21) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24CMA817; 22) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24EMI161; 23) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24IMH330; 24) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24LMB440; 25) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 25CMC121; 26) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 25FMC026; 27) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABL131; 28) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABU817; 29) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBA521; 30) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBP552; 31) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21DBE120; 32) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21FBE311; 33) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBG761; 34) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBS468; 35) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21HBN643; 36) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21JBB951; 37) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21LBL164; 38) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22BBT015; 39) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22DBD203; 40) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBA074; 41) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBO542; 42) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBC967; 43) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBF303; 44) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22IBE871; 45) DYKMBNDL138, UDI-DI: 101934
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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