Covidien LP

42 devices in the database

  • 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.
  • Model / Serial
    Batch Number: P9M0113, P9M0312, P9M0515, P9M0516, P9M0647, P9M0696, P9M0771,  P9M0816. Expanded Recall 6/23/10: P9H1081, P9M0113, P0A0021,P0A0723, P0B0753
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Auto Suture ProTack Fixation 5 mm || Product Catalogue # 174006. || Has application in endoscopic surgery procedures.
  • Model / Serial
    Lot Numbers: N2J0150X through N3C0683X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
  • Product Description
    Versaport Bladeless Optical Fixation Cannula - 5mm || Product Code: ONBFCA5ST || The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
  • Model / Serial
    Lot Numbers: N2J0315X through N3A0389X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
  • Product Description
    Versaport Bladeless Optical Fixation Cannula - 5mm Short || Product Code: ONBFCA5SH || The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
  • Model / Serial
    Lot Numbers: N2J0211X through N3D0118X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
  • Product Description
    Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm || Product Code: ONB5STF2C || The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
37 more

8 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Covidien LP, 5920 Longbow Dr, Boulder CO 80301-3202
  • Source
    USFDA
  • Manufacturer Address
    Covidien LP (formerly Nellcor Puritan Bennett Inc.), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 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
  • Manufacturer Address
    Covidien LP, 1430 Marvin Griffin Rd, Augusta GA 30906-3851
  • 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
  • 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
    ALIMSA
  • Manufacturer Address
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 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
3 more