Device Recall autosuture

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: A0K0490 Exp Date: 2015-10
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including CA, CT, FL, HI, IL, IN, KS, MA, MD, MI, MN, NC, NJ, NY, OH, PA, SC, TX, and WI and the countries of Canada and Italy
  • 제품 설명
    AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile || REF SPM 35 || Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength and tensile strength. Surgipro comes in multiple designs, including multi-filament and open weave. All designs are knitted in such a fashion as to provide bi-directional elasticity, while allowing the mesh to be cut to any shape without unraveling. || Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a non-absorbable mesh during and after wound healing.
  • Manufacturer
  • 1 Event

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 9 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: N4G110 N4H201 N4K213 N4L82 N4M302 N4M522
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • 제품 설명
    ChemoSite Catheter Introducer Kit with 9 French Peel-Away Sheath || Catalog Number: 120039
  • Manufacturer
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    Lot Numbers: N4J395 N4K343
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • 제품 설명
    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit || Catalog Number: 120011
  • Manufacturer
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    Lot Numbers: N4G435 N4J328 N4K344 N5A181
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • 제품 설명
    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit || Catalog Number: 120021
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: N4J52 N4J329 N4J379
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • 제품 설명
    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with 9 French Introducer Kit with Silicone Catheter || Catalog Number: 120025
  • Manufacturer
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    Lot Numbers: N4G22 N4G215 N4G436 N4J29 N4J212 N4K218 N4L258 N4M213
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • 제품 설명
    ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit || Catalog Number: 120045
  • Manufacturer
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