| Class 2 Device Recall Cuffed central venous catheter | |
Date Initiated by Firm | June 20, 2011 |
Date Posted | July 11, 2011 |
Recall Status1 |
Terminated 3 on March 01, 2012 |
Recall Number | Z-2783-2011 |
Recall Event ID |
59115 |
510(K)Number | K051417 |
Product Classification |
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
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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 UT 84116-3738
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For Additional Information Contact | 801-522-5614 |
Manufacturer Reason for Recall | Kit label indicates the wrong dimension for an enclosed introducer. |
FDA Determined Cause 2 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LJS
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