FDA Medical Device Recalls (openFDA)
B. Braun Interventional Systems: 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.)
- Recall number
- Z-0264-2008
- Recalling firm
- B. Braun Interventional Systems
- 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.)
- Status
- Terminated
- Initiated
- 2007-10-30
- Posted
- 2007-11-24
- Terminated
- 2008-03-02
- Reason
- Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.
- Root cause
- 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
- 60 units
- Distribution
- Nationwide: States of AL, GA, PA, FL, NE, WI, IL, LA, TX, AZ, MN, MA, CA, NY, OH, IN, and MI.
- Lot, serial or model codes
- Catalog #: 5010024, Model Number: 40DLP, Lot #: 0709240V
- 510(k) numbers
- ["K010485","K063217"]
- PMA numbers
- not on file
- Product code
- DTK
- Firm FEI
- 3006332832
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28