Devices

Device Recall 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG Nano TConnector, Clamp, Rotating Luer

  • Model / Serial
    Lot number 3422861, UDI (01) 0 0840619 09588 8 (17) 200301 (30) 01 (10) 3422861; lot number 3489493, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3489493; lot number 3498769, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498769; and lot number 3498773, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498773.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
  • Product Description
    14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. || The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s 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