Z-0873-06

Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in...

Name: Z-0873-06 Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in...
Creator: Kinetic Concepts, Inc
Published: 2006-03-17
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2006-03-17 / Terminated

FDA source

Kinetic Concepts, Inc began a recall of 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... on 2006-03-17. The reason FDA records is "Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0873-06
Status: Terminated
Initiated: 2006-03-17
Posted: 2006-05-23
Terminated: 2006-11-22
Recalling firm: KCI USA, Inc.
Product: 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***''.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
FDA root cause: Other
Action: Firm sent correction letters on 03/17/06 to all customers who purchased the device since May 2005.
Quantity in commerce: 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.
Product codes and lots: 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.

Product code FTL

K022011Class IIV.a.c. Abdominal DressingKinetic Concepts, Inc. / cleared 2003-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)