| | Class 2 Recall
Cuffed central venous catheter |  |
| Date Posted |
July 11, 2011 |
| Recall Number |
Z-2783-2011 |
| 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. |
| Code Information |
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.
|
Recalling Firm/
Manufacturer |
Bard Access Systems
605 North 5600 West
Salt Lake City, Utah 84116-3738 |
| Consumer Instructions |
Contact the recalling firm for information |
Reason for
Recall |
Kit label indicates the wrong dimension for an enclosed introducer.
|
| 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 in Commerce |
6,485 units |
| Distribution |
Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada. |
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