Recall Z-0873-06 ยท FTL Mesh, Surgical, Polymeric
Kinetic Concepts, Inc
Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufactured for Corporate Headquarters: KCI USA, Inc., 8023 Vantage Dr., San Antonio, TX 78230 USA***''.
| Date | May 23, 2006 (initiated Mar 17, 2006) |
| Status | Terminated |
| Reason | Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds. |
| Root cause | Other |
| Action | Firm sent correction letters on 03/17/06 to all customers who purchased the device since May 2005. |
| Quantity | 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 Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022011 | V.A.C. ABDOMINAL DRESSING Kinetic Concepts, Inc., Feb 26, 2003 |