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***''.
This recall has been terminated (originally issued May 23, 2006).
- 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
- Official Source
- View on FDA website ↗
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.