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.)
FDA Recall Z-0264-2008 · Posted 2007-11-24
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Recalling FirmB. Braun Interventional Systems
Recall StatusTerminated
Product CodeDTK
Date Initiated2007-10-30
Date Terminated2008-03-02
Product Quantity60 units
Reason for Recall
Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide: States of AL, GA, PA, FL, NE, WI, IL, LA, TX, AZ, MN, MA, CA, NY, OH, IN, and MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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