VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
FDA device recall Z-0132-2008 · posted 2007-12-15 · Terminated
Recall details
- Recalling firm
- VNUS Medical Technologies Inc
- Reason for recall
- Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.
- Action taken
- The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 92 units
- Distribution
- Nationwide: Product was distributed to 18 health care providers and medical centers throughout the US in the following states: TX, UT, CA, CT, MI, NY, MI, OR, WA, VA, PA, and NJ.
- Date initiated
- 2007-03-06
- Date posted
- 2007-12-15
- Date terminated
- 2007-12-17
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 (K061373) | Vnus Medical Technologies, Inc. | 2006-08-01 |