Device Recall Covidien

  • Modèle / numéro de série
    Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
  • Description du dispositif
    Covidien Argyle Infant Heel Warmers (no tab) || Item Code: MH00002N || Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Codes: 525157164X 524356164X  522957364X  522355664X  521058064X  520856764X  520159364X
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Description du dispositif
    Covidien Dover CATCH KIT SOAP || Item Code: 5205 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modèle / numéro de série
    Lot Codes: 522959464X 525757064X
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot Codes: 523657764X
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Description du dispositif
    Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP || Item Code: 24035 || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modèle / numéro de série
    Lot Codes: 518151164X 519450564X 520850264X 521250764X 522951064X 525150364X 525251064X
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Description du dispositif
    Covidien Dover MIDSTREAM KIT CASTILE SOAP || Item Code: 2040SA || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modèle / numéro de série
    Lot Codes: 512590564X 516087864X 517488664X 518889264X 520288264x 521689164X
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Description du dispositif
    Covidien Dover MIDSTREAM KIT CASTILE SOAP || Item Code: 2090SA || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
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