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***''.
- Company
- Kinetic Concepts, Inc
- Recall Initiated
- March 17, 2006
- Posted
- May 23, 2006
- Terminated
- November 22, 2006
- Recall Number
- Z-0873-06
- Quantity
- 6453 total units.
- Firm Location
- San Antonio, TX
Reason for Recall
Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
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.
Lot / Code Info
Lot Codes: 05.13.05.01; 05.24.05.16; 06.09.05.24; 06.15.05.13; 07.06.05.08; 07.13.05.05.03; 07.14.05.06; 07.19.05.10; 07.28.05.15; 08.03.05.15; 08.10.05.15; 08.17.05.18; 08.17.05.30; 08.17.05.31; 09.07.05.23; 09.21.05.16; 09.28.05.16; 10.05.05.29; 10.19.05.22; 12.28.05.06; 01.11.06.16; 02.01.06.15; 02.01.06.16; 02.15.06.23; 02.15.06.24.
Root Cause
Other
Action Taken
Firm sent correction letters on 03/17/06 to all customers who purchased the device since May 2005.