Recall Z-2783-2011 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Bard Access Systems
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 wel
| Date | Jul 11, 2011 (initiated Jun 20, 2011) |
| Status | Terminated |
| Reason | Kit label indicates the wrong dimension for an enclosed introducer. |
| Root cause | Labeling design |
| Action | 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. |
| Quantity | 6,485 units |
| Distribution | Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051417 | 6 FR FL POWERHOHN AND POWERLINE CATHETER C.R. Bard, Inc., Jun 30, 2005 |