Device Recall Covidien

  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: ¿esk¿ republika, ASSAGAY, Australia, Austria, Belgium, Bosnia, Herzegovina, Bulgaria Cairo,Egypt, Canada, Canary Islands, China, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kingdom of Bahrain, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Luxembourg, Nederland, Nelspruit, New Redruth, New Zealand, Norway, Nouvelle Caledonie, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Romania, Rustenburg, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Taiwan, Thailand, Tunisia, Uae, Uae - Dubai, Umhlanga Rocks, United Kingdom, Vietnam and Wales.
  • 제품 설명
    DUET TRS 60 4.8MM ARTICULATING SULU || Product Code: DUET6048A || Product Usage: || The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. When used with the ENDO GIA Universal and Ultra Staplers, the Duet TRS Reloads with Biosyn tissue reinforcement place two, triple-staggered rows titanium staples while simultaneously dividing the tissue and anchoring the preloaded Biosyn reinforcement material. The preloaded reinforcement material Is fully detached from the SULU upon complete firing of the length of the cartridge. The Duet TRS reinforcement material (Biosyn) Is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate.
  • Manufacturer
  • 8 Events

제조사

  • 제조사 주소
    Covidien LP, 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:  511851364X 512550364X 515357964X 518150364X 520150964X 523656964X 524356864X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (nationwide) and to Canada.
  • 제품 설명
    Covidien Dover PREC PRM 16FR SILVER FLY TY || Item Code: PP16XSD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code: 521807764X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
  • 제품 설명
    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. || Intended for pediatric feeding.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code: 521808064X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
  • 제품 설명
    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. || Intended for pediatric feeding.
  • Manufacturer
  • 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: 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
하나 더 71 건 더