Covidien LP

4 devices in the database

  • Model / Serial
    Lot No.: 188856, 190048, 190107, and 190307 through 193333 (88 lots).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.
  • Product Description
    Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 || Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.
  • Model / Serial
    Product Number: CTRF117 and CTRF220. Lot numbers: C4K101C thru C4K122C, C4K126C thru C4K133C, C4L134C thru C4L147C, C5A148C thru C5A158C, C5B159C thru C5B174C, C5C175C thru C5C191C, C5D192C thru C5D199C, C5E200C thru C5E213C, C5F214C thru C5F231C, C5G232C thru C5G235C, C5H236C thru C5H241C, C5I242C thru C5I246C, C5J247C thru C5J263C, C5K264C thru C5K272C, C5L273C thru C5L282C, C6A283C thru C6A286C.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. AZ, CA, CO, CT, FL, GA, IL, MA, MI, MN, MO, MS, NC, NE, NJ, OH, OK, PA, TX, VA. Foreign distribution to Argentina, Canada, Chile, Costa Rica, France, Greece, Israel, Peru, Singapore.
  • Product Description
    Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.
  • Model / Serial
    Catalog Number LS1120. Lot numbers: Any lot number beginning with N2, N3, N4, or N5A through N5L235K.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan, Mexico, Paraguay, Peru, Singapore, South Africa, Uruguay, Venezuela.
  • Product Description
    LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider
  • Model / Serial
    Catalog Number LS1100. Lot Numbers: Any lot number beginning with U, N2, N3, N4, or N5A through N5L247K.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan, Mexico, Paraguay, Peru, Singapore, South Africa, Uruguay, Venezuela.
  • Product Description
    LigaSure Atlas Laparoscopic Vessel Sealer/Divider

8 manufacturers with a similar name

Learn more about the data here

  • 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
    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
  • 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