Devices

Device Recall 10" Smallbore Ext Set

  • Modèle / numéro de série
    Lot No. 3040897, 3085194, 3100137, 3125469, 3136083, 3284928, 3288396, 3309182. Item No. AM6100
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
  • Description du dispositif
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. || Product Usage: || The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
  • Manufacturer
    ICU Medical, Inc.
  • 1 Event

Fabricant

ICU Medical, Inc.
  • Adresse du fabricant
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Société-mère du fabricant (2017)
    ICU Medical, Inc.
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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Device Recall 10" Smallbore Ext Set
  • Modèle / numéro de série
    Lot No. 3182596, 3204086, 3246762, 3263682, 3295482. Item No. AM6109
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
  • Description du dispositif
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. || Product Usage: || The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
  • Manufacturer
    ICU Medical, Inc.
Device Recall 10" Smallbore Ext Set
  • Modèle / numéro de série
    Lot No. 3321776. Item No. AM6122
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
  • Description du dispositif
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. || Product Usage: || The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
  • Manufacturer
    ICU Medical, Inc.