Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.***
FDA device recall Z-0873-06 · posted 2006-05-23 · Terminated
Recall details
- Recalling firm
- Kinetic Concepts, Inc
- Reason for recall
- Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
- Action taken
- Firm sent correction letters on 03/17/06 to all customers who purchased the device since May 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 6453 total units.
- Distribution
- Product distributed nationwide and to the following countries: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerlan
- Date initiated
- 2006-03-17
- Date posted
- 2006-05-23
- Date terminated
- 2006-11-22
- Location
- San Antonio, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V.A.C. ABDOMINAL DRESSING (K022011) | Kinetic Concepts, Inc. | 2003-02-26 |