Device Recall Covidien

  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 522959464X 525757064X
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US (nationwide) and to Canada.
  • 제품 설명
    Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL || Item Code: 24015 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 76 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 525157164X 524356164X  522957364X  522355664X  521058064X  520856764X  520159364X
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US (nationwide) and to Canada.
  • 제품 설명
    Covidien Dover CATCH KIT SOAP || Item Code: 5205 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 523657764X
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US (nationwide) and to Canada.
  • 제품 설명
    Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP || Item Code: 24035 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 518151164X 519450564X 520850264X 521250764X 522951064X 525150364X 525251064X
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US (nationwide) and to Canada.
  • 제품 설명
    Covidien Dover MIDSTREAM KIT CASTILE SOAP || Item Code: 2040SA || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 512590564X 516087864X 517488664X 518889264X 520288264x 521689164X
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US (nationwide) and to Canada.
  • 제품 설명
    Covidien Dover MIDSTREAM KIT CASTILE SOAP || Item Code: 2090SA || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 513287864X 514688164X 518187764X 520288464X 523087364X
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US (nationwide) and to Canada.
  • 제품 설명
    Covidien Dover MIDSTREAM KIT RING CASTILE || Item Code: 4090SA || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
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