Devices

Device Recall 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave, Orange Ring, 2

  • Model / Serial
    Item No. 011-A1097. Lot No. 2781155, 2796667.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
  • Product Description
    31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 || Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConnector, || Rotating Luer, Part No. A1000, Item No. 011-A1097 || The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
  • 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