| Class 2 Device Recall B. Braun (BIS) VenaTech LP Vena Cava Filter System | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DTK 510(K)s with Product Code = DTK
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