Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit

  • Modèle / numéro de série
    Lot Number 0001047501
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
  • Description du dispositif
    AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION || Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Société-mère du fabricant (2017)
  • Source
    USFDA