Devices

Device Recall 10" Smallbore Ext Set

  • Model / Serial
    Lot No. 3040897, 3085194, 3100137, 3125469, 3136083, 3284928, 3288396, 3309182. Item No. AM6100
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
  • Product Description
    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

Manufacturer

ICU Medical, Inc.
  • Manufacturer Address
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall 10" Smallbore Ext Set
  • Model / Serial
    Lot No. 3182596, 3204086, 3246762, 3263682, 3295482. Item No. AM6109
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
  • Product Description
    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
  • Model / Serial
    Lot No. 3321776. Item No. AM6122
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
  • Product Description
    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.