Device Recall Arrow gard Blue PLUS Central Venous Catheter

  • Modèle / numéro de série
    Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM  Lot # 13F16L0105, 23F16K0180 and 13F16L0199
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to NJ, IL, and PA
  • Description du dispositif
    Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. || Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
  • Source
    USFDA