Device Recall BD Vacutainer PLUS K2EDTA Blood Collection Tubes

  • 모델명 / 제조번호(시리얼번호)
    Catalog Reference #367844; Lot number 5154624  Catalog Reference #367862; Lot numbers 5089771 and 5187753  Catalog Reference #368021; Lot number 5089820
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
  • 제품 설명
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

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  • 모델명 / 제조번호(시리얼번호)
    Catalog Reference #368047; Lot number 5154647
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
  • 제품 설명
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory.The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog Reference #368054; Lot numbers 5089827, 5210514, 5154646, 5210511.  Catalog Reference #367856; Lot number 5064666
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
  • 제품 설명
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.
  • Manufacturer