Device Recall Cuffed central venous catheter

  • Model / Serial
    Lot Numbers: REPG0515, RERF0625, RERH0766, rerj0831, RERL0171, RESA0362, RESB0115, RESC0022, RESH0242, RESH0436, RESJ0421, RETD0946, RETE0613, RETE0676, RETF0510, RETH0051, RETH0672, RETK0471, RETK1024, REUA0207, reua0795, REUB0565, REUB0891, REUD0314, REUE891, reue1155, reuf0351, REUG0994, REUG1615, REUH1366, REUI0642, REUJ0665, REUK0190, REUL0817, REVA1056, revb0515.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.
  • Product Description
    Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico. || Product Usage: Designed for short or long term access to the central venous system. They are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • Manufacturer Parent Company (2017)
  • Source
    USFDA