Device Recall Covidien

  • Model / Serial
    Lot Codes: 513256264X 515358164X 517457064X 520550064X 520857464X 521058564X 522958064X 525153264X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover P400 PREM U/M 16FR SLVR FLY || Item Code: P4P16XSD || 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:  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
  • Model / Serial
    Lot Code: 521808064X
  • 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 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. || Intended for pediatric feeding.
  • Manufacturer
  • Model / Serial
    Lot Codes: 525157164X 524356164X  522957364X  522355664X  521058064X  520856764X  520159364X
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover CATCH KIT SOAP || Item Code: 5205 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Model / Serial
    Lot Codes: 522959464X 525757064X
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL || Item Code: 24015 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
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