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

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 0001047501
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • 제조사 모회사 (2017)
  • Source
    USFDA