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.
FDA Recall Z-2783-2011 · Posted 2011-07-11
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Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeLJS
Date Initiated2011-06-20
Date Terminated2012-03-01
Product Quantity6,485 units
Reason for Recall
Kit label indicates the wrong dimension for an enclosed introducer.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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