Device Recall autosuture

  • Model / Serial
    Lot Number: A0K0490 Exp Date: 2015-10
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    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
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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

9 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: N4G110 N4H201 N4K213 N4L82 N4M302 N4M522
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • Product Description
    ChemoSite Catheter Introducer Kit with 9 French Peel-Away Sheath || Catalog Number: 120039
  • Manufacturer
  • Model / Serial
    Lot Numbers: N4J395 N4K343
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • Product Description
    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit || Catalog Number: 120011
  • Manufacturer
  • Model / Serial
    Lot Numbers: N4G435 N4J328 N4K344 N5A181
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • Product Description
    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit || Catalog Number: 120021
  • Manufacturer
  • Model / Serial
    Lot numbers: N4J52 N4J329 N4J379
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • Product Description
    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with 9 French Introducer Kit with Silicone Catheter || Catalog Number: 120025
  • Manufacturer
  • Model / Serial
    Lot Numbers: N4G22 N4G215 N4G436 N4J29 N4J212 N4K218 N4L258 N4M213
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • Product Description
    ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit || Catalog Number: 120045
  • Manufacturer
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