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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2113-2026

Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 12) MINOR EYE PACK, Model Number: DYNJ17219C; 13) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 14) EYE PACK, Model Number: DYNJ41207C; 15) OPHTHALMIC PACK, Model Number: DYNJ42043I; 16) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 17) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 18) EYE PLASTIC PACK, Model Number: DYNJ47859B; 19) EYE PLASTIC PACK, Model Number: DYNJ47859C; 20) CATARACT PACK, Model Number: DYNJ53019A; 21) CATARACT PACK, Model Number: DYNJ54869A; 22) VITRECTOMY PACK, Model Number: DYNJ55280B; 23) NDNW-EYE PACK, Model Number: DYNJ61779C; 24) EYE PK, Model Number: DYNJ62306; 25) VITRECTOMY, Model Number: DYNJ64220; 26) OSC BREAST PACK, Model Number: DYNJ65808C; 27) MILLS CATARACT PACK, Model Number: DYNJ67973A; 28) EYE PACK, Model Number: DYNJ68367B; 29) CATARACT PACK, Model Number: DYNJ68875D; 30) CATARACT PACK, Model Number: DYNJ68875F; 31) CATARACT PACK, Model Number: DYNJ68875G; 32) VITRECTOMY IP, Model Number: DYNJ84020; 33) PLASTIC PACK, Model Number: DYNJ86288; 34) OPHTHO PLASTIC, Model Number: DYNJ902256C; 35) RETINAL, Model Number: DYNJ907495; 36) CATARACT, Model Number: DYNJ909924; 37) CATARACT, Model Number: DYNJ909924A; 38) COMBO EYE, Model Number: DYNJ909925; 39) VITRECTOMY, Model Number: DYNJ909929; 40) RETINAL PK-LF, Model Number: DYNJC2364O

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) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21ABV400; 2) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21FBP706; 3) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21IBV636; 4) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 22GBP895; 5) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22HBX475; 6) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS899; 7) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS907; 8) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22KBO773; 9) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 23HBV380; 10) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 24EBU650; 11) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 25HBK503; 12) DYKMBNDL159, UDI-DI: 10193489478273(each), 40193489478274(case), Lot Number: 21ABQ655; 13) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21ABT655; 14) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21BBM375; 15) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21FBP773; 16) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ABR620; 17) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21BBK655; 18) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21FLA394; 19) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21HLA179; 20) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ILA655; 21) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21KLA277; 22) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23CBP086; 23) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23DBD264; 24) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23CBP088; 25) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23EBL613; 26) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23FBU438; 27) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23GBE628; 28) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23IBA614; 29) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23JBK353; 30) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23KBJ008; 31) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23LBI221; 32) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24ABH891; 33) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24BBJ841; 34) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24CBA180; 35) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24EBF870; 36) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24HBS367; 37) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21ABT657; 38) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21DBC009; 39) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21GBJ364; 40) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 21IBP918; 41) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW517; 42) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW535; 43) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22FBB999; 44) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22GBW969; 45) DYK
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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