Covidien LLC

5 devices in the database

  • Model / Serial
    Model : 397310, 4034, 8047, 4031, 4037, 6022, 6056, 6522, 6534, 6545, 6556, 7319, 7321
  • Product Description
    Sponges for x-ray systems
  • Model / Serial
    Product numbers :- ONBFCA5ST, ONBFCA5SH, ONB5STF2C, ONB5STF, ONB5LGF, ONB5SHF, USUONB5LGF, USUONB5SHF, USUONB5STF, USUONBFCA5ST, Lot numbers NOT affected: N2H0045X, N2H0166X, N2H0286X, N2H0357X, N2H0516UX. Please see the attachment
  • Product Description
    Trocars, Abdominal , Thoracic , Cannulae
  • Model / Serial
    all OxiMax™ N-65 Handheld Pulse Oximeters (Product code: N65, N65-1, N65P & N65P-1) OxiMax™ N-560 Pulse Oximeters (Product code: N560)
  • Product Description
    Pulse Oximeter
  • Model / Serial
    Item Number: 31141784 Description: K-1960-S STANDARD MINI-KIT Item Number: 31140208 Description: 3611 FLEXBL LITE GLOVE 1EA/PKG Item Number: 31140216 Description: 3613 LITE GLV-FLEXIBLE 3EA/PKG Item Number: 31140257 Description: 3612 LITE GLV-FLEXIBLE 2EA/PKG Item Number: 571711 Description: NS-3600-B LITE GLOVE 1000/CASE
  • Product Description
    Light Handle
  • Model / Serial
    Neonatal applications (NeoMode software) on Puritan Bennett™ 980 (PB980) neonatal and universal ventilator models.
  • Product Description
    Ventilator System

62 manufacturers with a similar name

Learn more about the data here

  • 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
    TDMDAT
  • 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
    TDMDAT
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
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