Devices

Device Recall 28 cm (11") PUR Bifuse Ext Set

  • Model / Serial
    Lot No. 3303906. Item No. 011-AM6116
  • 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
    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, 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