Device Recall Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop

  • 모델명 / 제조번호(시리얼번호)
    Catalog/Model/Reorder Number: LGB Lot # 10-405
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
  • 제품 설명
    PALL Medical LeukoGuard¿ LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter, Blood, Cardiopulmonary Bypass Arterial Line. COMMON/USUAL NAME: Arterial Line Filter with Bypass Loop. -- Manufactured by: PALL NEWQUAY, CORNWALL, TR9 6TT, UK -- Device Listing # D000745. --- Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Pall Corporation, 25 Harbor Park Drive, Port Washington NY 11050-4605
  • 제조사 모회사 (2017)
  • Source
    USFDA