FDAFDA · Alimentos y medicamentos·N.º oficial Z-1132-2025
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG8 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGM 7) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGN 8) KIT,CHP SINUS ENDOSCOPY, Catalog Number:PE36ESCHA 9) KIT, SSSC ENT, Catalog Number:PECGOTSN1 10) KIT, SSSC ENT, Catalog Number:PECGOTSN2 11) KIT, SSSC ENT, Catalog Number:PECGOTSN3 12) KIT, SSSC ENT, Catalog Number:PECGOTSNA 13) KIT, SSSC ENT, Catalog Number:PECGOTSNB 14) KIT, SSSC ENT, Catalog Number:PECGOTSNC 15) KIT, SSSC ENT, Catalog Number:PECGOTSND 16) KIT, SSSC ENT, Catalog Number:PECGOTSNE 17) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10O 18) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10P 19) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10Q 20) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10R 21) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10S 22) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10T 23) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA10Y 24) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA110 25) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA112 26) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA113 27) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA114 28) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA115 29) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA116 30) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA117 31) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA118 32) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA119 33) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA120 34) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA121 35) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA123 36) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA124 37) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA125 38) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA126 39) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA127 40) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA128 41) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA129 42) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT101 43) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10A 44) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10B 45) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10D 46) KIT, MINOR ENT, MERCY, Catalog Number:PEVNMECHE 47) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PGV2OT10C 48) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH1 49) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH2 50) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH3 51) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCHA 52) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC1 53) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC2 54) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCB 55) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCC 56) ENDO SSOP PACK, Catalog Number:SBA23ENPCD 57) L T P PACK, Catalog Number:SEN11LTCH3 58) L T P PACK, Catalog Number:SEN11LTCH4 59) ENT PACK, Catalog Number:SEN12NSHHT 60) ENT PACK, Catalog Number:SEN12NSHHU 61) ENT, Catalog Number:SEN13ENRU5 62) ENT, Catalog Number:SEN13ENRU6 63) ENT, Catalog Number:SEN13ENRUH 64) NASAL PACK, Catalog Number:SEN13NSCOH 65) NASAL PACK, Catalog Number:SEN13NSCOI 66) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT3 67) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT4 68) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNTJ 69) SINUS ENT PACK, Catalog Number:SEN13SNNT1 70) SINUS ENT PACK, Catalog Number:SEN13SNNT2 71) SINUS ENT PACK, Catalog Number:SEN13SNNT3 72) STERILE SINUS ENT PACK, Catalog Number:SEN13SNNTL 73) ENT PACK, Catalog Number:SEN21EPHO1 74) ENT PACK, Catalog Number:SEN21EPHO2 75) ENT PACK, Catalog Number:SEN21EPHO3 76) ENT PACK, Cata
Publicado el 19 de febrero de 2025 · Inicio del retiro: 8 de noviembre de 2024
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
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cardinal Health 200, LLC
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- Lote
- 1) PE29NSFG4, UDI-DI:10195594302870 (each) 50195594302878 (case), Lot Number: 5140385 ; 2) PE29NSFG5, UDI-DI:10195594429980 (each) 50195594429988 (case), Lot Number: 5478805 ; 3) PE29NSFG6, UDI-DI:10195594510046 (each) 50195594510044 (case), Lot Number: 5664108 ; 4) PE29NSFG7, UDI-DI:10197106511206 (each) 50197106511204 (case), Lot Number: 7280115 ; 5) PE29NSFG8, UDI-DI:10197106535981 (each) 50197106535989 (case), Lot Number: 7320240 ; 6) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J3593N ; 7) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J46C07 ; 8) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J4952P ; 9) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679N ; 10) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679T ; 11) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J7905H ; 12) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6701854 ; 13) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7005491 ; 14) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7266056 ; 15) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7280114 ; 16) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J84K06 ; 17) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693H ; 18) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693K ; 19) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J6368Z ; 20) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 21) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 22) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5841390 ; 23) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5533340 ; 24) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6025794 ; 25) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6487916 ; 26) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6487917 ; 27) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6563985 ; 28) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6788522 ; 29) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7287564 ; 30) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7349687 ; 31) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7360443 ; 32) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6487899 ; 33) PECGOTSN1, UDI-DI:10195594910358 (each) 50195594910356 (case), Lot Number: J6278X ; 34) PECGOTSN2, UDI-DI:10195594573386 (each) 50195594573384 (case), Lot Number: 5841390 ; 35) PECGOTSN3, UDI-DI:10197106422984 (each) 50197106422982 (case), Lot Number: 7163105 ; 36) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J30T07 ; 37) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J46C05 ; 38) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J4952N ; 39) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J4952P ; 40) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J4952U ; 41) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J5679N
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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