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U.S. Department of Health and Human Services

Class 2 Device Recall Cuffed central venous catheter

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 Class 2 Recall
Cuffed central venous catheter
see related information
Date Posted July 11, 2011
Recall Status1 Terminated on March 01, 2012
Recall Number Z-2783-2011
Recall Event ID 59115
Premarket Notification
510(K) Number
Product Classification Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days - Product Code LJS
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/
Bard Access Systems
605 North 5600 West
Salt Lake City, Utah 84116-3738
Manufacturer Reason
for Recall
Kit label indicates the wrong dimension for an enclosed introducer.
FDA Determined
Cause 2
DESIGN: 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 in Commerce 6,485 units
Distribution Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = C.R. BARD, INC.