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U.S. Department of Health and Human Services

Class 2 Device Recall Hickman and Leonard Catheters

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 Class 2 Recall
Hickman and Leonard Catheters
see related information
Date Posted March 06, 2013
Recall Status1 Terminated on January 03, 2014
Recall Number Z-0910-2013
Recall Event ID 64425
Premarket Notification
510(K) Number
K830233 
Product Classification Introducer, Catheter - Product Code DYB
Product Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
Code Information Lot numbers: HUWI1379 and HUWI1380.
Recalling Firm/
Manufacturer
Bard Access Systems
605 North 5600 West
Salt Lake City, Utah 84116-3738
For Additional Information Contact Mr. Ramon Ricart
801-522-5568
Manufacturer Reason
for Recall
Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action Bard sent an Urgent Recall Notification letters dated February 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete the enclosed Reply Form and Inventory Reconciliation Form. For questions contact Bard Access Systems Customer Service at 1-800-290-1689.
Quantity in Commerce 73 units
Distribution USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
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 = DYB and Original Applicant = EVERMED, INC.
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