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U.S. Department of Health and Human Services

Class 2 Device Recall Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet

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  Class 2 Device Recall Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet see related information
Date Initiated by Firm May 01, 2006
Date Posted May 31, 2006
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-0913-06
Recall Event ID 35201
510(K)Number K915801  K936194  
Product Classification Biopsy Needle - Product Code FCG
Product Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687.

The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an outer cannula with an attached female luer lock hub, and inner stylet with an attached male luer lock hub, and a flexible slip rink depth stop.
Code Information Lot # REP JO196
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact Shari L Allen, RAC
480-303-2720
Manufacturer Reason
for Recall		 Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.
FDA Determined
Cause 2		 Other
Action Recall letters were sent to all consignees (Radiology Department Manager with a copy to the Hospital Administrator) via Federal Express overnight delivery with signature receipt required on May 1, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV).
Quantity in Commerce 225
Distribution The product was distributed to the following five states: 1) California, 2) Florida 3) New Jersey, 3) Missouri, 4) Texas, 5) Washington. The product was also distributed to Canada and Latin America. Note: units distributed to Latin America remained in Bard''s distribution system and have been returned.
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 = FCG and Original Applicant = BARD GYNECOLOGY AND RADIOLOGY
510(K)s with Product Code = FCG and Original Applicant = UNI-QUATRO INDUSTRIES CANADA, INC.
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