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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun (BIS) VenaTech LP Vena Cava Filter System

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  Class 2 Device Recall B. Braun (BIS) VenaTech LP Vena Cava Filter System see related information
Date Initiated by Firm October 30, 2007
Date Posted November 24, 2007
Recall Status1 Terminated 3 on March 02, 2008
Recall Number Z-0264-2008
Recall Event ID 45539
510(K)Number K010485  K063217  
Product Classification Vena Cava Filter System - Product Code DTK
Product Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP, B Braun. Manufacturer: B. Braun Medical 204, avenue du Marechal Juin BP 331 92107 Boulogne Cedex , France. (The VenaTech LP vena cava filter is pre-loaded in a syringe (cartridge) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either via the femoral or jugular approach.)
Code Information Catalog #: 5010024, Model Number: 40DLP, Lot #: 0709240V
Recalling Firm/
Manufacturer		 B. Braun Interventional Systems
14276 23rd Ave N
Plymouth MN 55447-4910
Manufacturer Reason
for Recall		 Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.
FDA Determined
Cause 2		 Packaging process control
Action B. Braun sent an Urgent Medical Device Removal letter (10/10/07) by express mail to each of the hospital accounts that received the recalled lot of VenaTech LP. B. Braun sales represenatatives will also contact each account directly to inquire if any inventory of the suspect lot remains and to provide guidance for return and replacement of any existing inventory.
Quantity in Commerce 60 units
Distribution Nationwide: States of AL, GA, PA, FL, NE, WI, IL, LA, TX, AZ, MN, MA, CA, NY, OH, IN, and MI.
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 = DTK and Original Applicant = B BRAUN
510(K)s with Product Code = DTK and Original Applicant = B. BRAUN MEDICAL, INC.
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