Device Recall Deltec branded PORTACATH II

  • Modèle / numéro de série
    M36262
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    To 11 facilities in FL, GA, ME, MN, NH, NJ, OK, TX, WI, WV and Peurto Rico. And to 2 international distributors (Canada and Taiwan).
  • Description du dispositif
    Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6 mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introducer Set. Immediate package states Contents of unopened and undamaged individual product packages are STERILE and non-pyrogenic. Check package integrity before use. Destroy after use. Do not resterilize. Latex free. Deltec, Inc. 1265 Grey Fox Road, St. Paul, MN 55112
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA