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U.S. Department of Health and Human Services

Class 3 Device Recall PICC catheters

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  Class 3 Device Recall PICC catheters see related information
Date Initiated by Firm December 20, 2005
Date Posted March 16, 2006
Recall Status1 Terminated 3 on August 11, 2009
Recall Number Z-0541-06
Recall Event ID 34518
510(K)Number K034020  K023374  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc.
Code Information Product code 7617405, Lot #REPI0344
Recalling Firm/
Manufacturer		 Bard Access Systems, Inc
5425 Amelia Earhart Dr
Salt Lake City UT 84116-3713
For Additional Information Contact
801-595-0700
Manufacturer Reason
for Recall		 Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 12/20/2005.
Quantity in Commerce 567 units
Distribution Nationwide, including VA facilities in CA, FL and IL. No foreign or military distribution.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = C.R. BARD, INC.
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