Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP, B Braun. Manufacturer: B. Braun Medical 20
FDA device recall Z-0264-2008 · posted 2007-11-24 · Terminated
Recall details
- Recalling firm
- B. Braun Interventional Systems
- Reason for recall
- Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DTK
- Quantity affected
- 60 units
- Distribution
- Nationwide: States of AL, GA, PA, FL, NE, WI, IL, LA, TX, AZ, MN, MA, CA, NY, OH, IN, and MI.
- Date initiated
- 2007-10-30
- Date posted
- 2007-11-24
- Date terminated
- 2008-03-02
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) (K063217) | B.Braun Medical, Inc. | 2007-01-12 |
| VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER (K010485) | Bbraun | 2001-05-18 |