Recall Z-2783-2011
Bard Access Systems · initiated June 20, 2011
Product
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.
Codes / lots: 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.
Reason for recall
Kit label indicates the wrong dimension for an enclosed introducer.
FDA-determined cause: Labeling design
Action taken
Bard Access Systems, Inc. notified customers by letter dated June 16, 2011. The letter notified customers of the mislabeling issue and offered a replacement product if desired. For additional information contact Bard Access Systems at 1-800-443-3393.
Details
- Recall number
- Z-2783-2011
- Initiated
- June 20, 2011
- Posted by FDA
- July 11, 2011
- Terminated
- March 1, 2012
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Quantity
- 6,485 units
- Distribution
- Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.
- Recalling firm
- Bard Access Systems, Salt Lake City, UT