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.)
This recall has been terminated (originally issued November 24, 2007).
- Company
- B. Braun Interventional Systems
- Recall Initiated
- October 30, 2007
- Posted
- November 24, 2007
- Terminated
- March 2, 2008
- Recall Number
- Z-0264-2008
- Quantity
- 60 units
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.
Distribution
Nationwide: States of AL, GA, PA, FL, NE, WI, IL, LA, TX, AZ, MN, MA, CA, NY, OH, IN, and MI.
Lot / Code Info
Catalog #: 5010024, Model Number: 40DLP, Lot #: 0709240V
Root Cause
Packaging process control
Action Taken
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.