Device Recall Covidien

  • 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
  • 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)
    All lot numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. || Product Code: DUET6048A. || Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
  • 제품 설명
    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm || Product Code: 030450 || Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model # 10007101; Lot # 14A0041IN
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
  • 제품 설명
    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. || The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model # 10116080 ; Lot # PO643063
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
  • 제품 설명
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. || The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model BVT608010, Lot numbers: 9853174, 9864497, 9890772, 9890931, 9925676, 9932672, 9937308, 9937315, 9940474, 9940614, 9976340, 9978233, A001589, A001740.   Model BVT608030, Lot Numbers: 9853331, 9887597, 9887695, 9887757, 9932042.   Model BVT612010, Lot numbers: 9854121, 9868214, 9868311, 9875472, 9875632, 9876174, 9883295, 9884788, 9884951, 9886196, 9886312, 9932096, 9968511, 9974109, 9974126, 9976472, 9977091, 9978862, A002299, A002423.   Model BVT312030, Lot numbers: 9854124, 9892081, 9941213, 9971096, 9971139, 9976506, 9977140, 9978964, 9979548, A003021, A003121, A003651, A007900, A008492, A008603, A008687.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • 제품 설명
    Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. || Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
  • Manufacturer
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