Device Recall Pediatric DirectWired Disposable Defibrillation/Pacing Electrodes

  • Modèle / numéro de série
    Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of OH and TX.
  • Description du dispositif
    GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . || Product Usage: Usage: || Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Leonhard Lang Gmbh, Archenweg 56, Innsbruck Austria
  • Société-mère du fabricant (2017)
  • Source
    USFDA