Device Recall Covidien

  • Modelo / Serial
    Lot Codes: 520857564X 522553864X 522958164X 523656864X 525153364X 525755664X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Affected Lot Range: 210141X through 61220104X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Descripción del producto
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes || Item Code: E253028 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Modelo / Serial
    Affected Lot Range: 210286X through 61220102X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Descripción del producto
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" || Item Code: E25306 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Modelo / Serial
    Affected Lot Range: 210573X through 60870080X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Descripción del producto
    Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM || Item Code: E258028 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Modelo / Serial
    Affected Lot Range: 211742X through 60870082X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Descripción del producto
    Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM || Item Code: E258128 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Modelo / Serial
    Affected Lot Range: 216416X through 60080002X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Descripción del producto
    Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM || Item Code: E258228 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
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