Device Recall Primary Checkvalve for Secondary (piggyback) Administration Set

  • 모델명 / 제조번호(시리얼번호)
    Model # I8C4220 (Reorder No. 21-0349-25) distributed outside the United States contains Lot No. FEB04T24 & MAR04T14. Model # 8C4220 (Reorder No. 21-0328-01) distributed within the United States contains Lot No.: MAR04T21 & APR04T08.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    worldwide.
  • 제품 설명
    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Primary Checkvalve Set for secondary (piggyback) Administration described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C4220 (Reorder No. 21-0349-25) for product distributed Internationally. Model Number 8C4220 (Reorder No. 21-0328-01) for product distributed within the United States.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA

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

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    FEB04T31, MAR04T22 & APR04T19 distributed within the united States.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    worldwide.
  • 제품 설명
    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve for Secondary (piggyback) Administration Set described as 115 inch length/292 cm, 27ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    APR04T24 distributed within the United States.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    worldwide.
  • 제품 설명
    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NC1301 (Reorder No. 21-0428-01) Primary Checkvalve for Secondary (piggyback) Administration Set described as 115 inch length/292 cm, 27ml priming volume, 20 drops/ml and 3 Luer-activated Valve Injection sites.
  • Manufacturer