Device Recall FemFlex II Pediatric Femoral Arterial Cannula

  • Modèle / numéro de série
    Model/Lot Numbers: FEMII008A/59751073, 59775775, 59775776, 59775777 & 59852930; FEMII008AT/59807985, 59867050, & 59873263;  FEMII008V/59873250 & 59873251; FEMII010A/59740468, 59773806, 59792415, 59792416 & 59852934;  FEMII010AT/ 59747819, 59807986,59852935, 59890916 & 59896910; FEMII010V/59751074, 59849119 & 59890924; FEMII012A/ 59801792,59867064, 59884766 & 59884778  FEMII012AT/59852940 & 59867051; and  FEMII012V/59723307, 59796683, 59849124 & 59873252
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. || Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Société-mère du fabricant (2017)
  • Source
    USFDA