Device Recall Covidien

  • Model / Serial
    Lot Codes: 511059464X 511851964X 513256664X 514650264X 515358464X 516050764X 516858564X 517457464X 520151064X 521058864X 522551264X 522958464X 523657064X 524357064X 525755764X 525755864X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover PRECSION PRM 16FR SIL FLY || Item Code: PP16SD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Covidien LLC, 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

76 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Codes: 511752564X 516054164X 520853264X 525450264X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover P400 UM 18FR SIL COUDE SECURE || Item Code: P4P18CSDK || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Model / Serial
    Lot Codes: 520857564X 522553864X 522958164X 523656864X 525153364X 525755664X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover P400 PREM U/M 18FR SIL FLY || Item Code: P4P18SD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Model / Serial
    Lot Codes: 516050964X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover P400 PREM U/M 18FR UL FOLY CSD || Item Code: P4P18ULD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Model / Serial
    Lot Codes:  511851364X 512550364X 515357964X 518150364X 520150964X 523656964X 524356864X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover PREC PRM 16FR SILVER FLY TY || Item Code: PP16XSD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Model / Serial
    Lot Code: 521807764X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
  • Product Description
    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. || Intended for pediatric feeding.
  • Manufacturer
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