Device Recall Fresenius Optiflux F250NRe Hemodialyzer

  • Modèle / numéro de série
    Lot Codes: 8SU203 EXPIRATION DATE: 12/31/2011, 8SU204 EXPIRATION DATE: 12/31/2011, 8SU205 EXPIRATION DATE: 12/31/2011, 09DU02013 EXPIRATION DATE: 04/30/2012, 09DU02014 EXPIRATION DATE: 04/30/2012, 09DU02022 EXPIRATION DATE: 04/30/2012, 09NU02011 EXPIRATION DATE: 10/31/2012, 09PU02011 EXPIRATION DATE: 11/30/2012, 09SU02001 EXPIRATION DATE: 12/31/2012, 09SU02007 EXPIRATION DATE: 12/31/2012, 10AU02013 EXPIRATION DATE: 01/31/2013, 10CU02001 EXPIRATION DATE: 03/31/2013, 10EU02010 EXPIRATION DATE: 05/31/2013, 10EU02017 EXPIRATION DATE: 05/31/2013, 10HU02013 EXPIRATION DATE: 06/30/2013, 10HU02014 EXPIRATION DATE: 06/30/2013, 10LU02001 EXPIRATION DATE: 09/30/2013, 10LU02013 EXPIRATION DATE: 09/30/2013, 10LU02014 EXPIRATION DATE: 09/30/2013, 10LU02015 EXPIRATION DATE: 09/30/2013
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the country of Canada.
  • Description du dispositif
    Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis || Catalog No. 0500325E || The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Société-mère du fabricant (2017)
  • Source
    USFDA