FDAFDA · Alimentos y medicamentos·N.º oficial Z-2101-2026
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CART, Model Number: ACC010542; 6) DRAWER 2 NEURO CART, Model Number: ACC010543; 7) DRAWER 4, Model Number: ACC010722; 8) SUCTION TRAY, Model Number: ACC010862; 9) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896;
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) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB175; 2) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB692; 3) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21LDA438; 4) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22BDB172; 5) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22HDA973; 6) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23ADA426; 7) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23BDA230; 8) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23CDC052; 9) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23CDA732; 10) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23IDB293; 11) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23LDB309; 12) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23LDB516; 13) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24ADA088; 14) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24ADA521; 15) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24ADB169; 16) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24EDB837; 17) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24GDA256; 18) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24IDA878; 19) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24JDB721; 20) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24LDA585; 21) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24LDA831; 22) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 25ADB193; 23) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 25BDB349; 24) ACC010326B, UDI-DI: 10198459292415(each), 40198459292416(case), Lot Number: 25CDB013; 25) ACC010326B, UDI-DI: 10198459292415(each), 40198459292416(case), Lot Number: 25CDB192; 26) ACC010326B, UDI-DI: 10198459292415(each), 40198459292416(case), Lot Number: 25DDA331; 27) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 21BDA319; 28) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22JDB707; 29) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22KDB086; 30) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22LDA361; 31) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDA657; 32) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDB192; 33) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDC028; 34) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23KDB009; 35) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 24CDA302; 36) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 24DDB115; 37) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 24DDB561; 38) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 24IDB266; 39) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 25ADA506; 40) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 25CDA517; 41) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 25CDB100; 42) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 25FDA012; 43) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 21KDA051; 44) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22DDB648; 45) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Numb
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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