FDA Recall
Terminated
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***''.
Recall: Z-0873-06
·
Initiated March 17, 2006
Recall
- Recall Number
- Z-0873-06
- Event Number
- 35089
- Firm
- Kinetic Concepts, Inc
- FEI Number
- 1625774
- Product Code
- FTL
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 17, 2006
- Posted
- May 23, 2006
- Terminated
- November 22, 2006
- Address
- 4958 Stout Dr, San Antonio, TX, 78219-4334
Description
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***''.
Reason
Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
Action
Firm sent correction letters on 03/17/06 to all customers who purchased the device since May 2005.
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.
Quantity
6453 total units.