Z-0038-05

V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5...

Name: Z-0038-05 V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5...
Creator: Kinetic Concepts, Inc
Published: 2004-09-21
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2004-09-21 / Terminated / root cause: packaging

FDA source

Kinetic Concepts, Inc began a recall of V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc... on 2004-09-21. The reason FDA records is "The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0038-05
Status: Terminated
Initiated: 2004-09-21
Posted: 2004-10-22
Terminated: 2005-06-07
Recalling firm: KCI USA, Inc.
Product: V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall: The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.
Root cause tag: packaging
FDA root cause: Other
Action: The firm initiated the recall by letter and phone calls on September 21, 2004.
Quantity in commerce: 29610 units
Distribution: The product was distributed to hospitals and clinics nationwide. The product was also shipped to the following foreign countries: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Qatar, Phillipines, United Arab Emirates, Ireland, Italy, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Part M6275043-5: 01.27.04.21v; 01.27.04.22v; 01.27.04.23v; 02.23.04.03; 05.06.04.07; 05.17.04.01; 05.20.04.08; 06.23.04.12; 07.07.04.13; and 08.11.04.04 Part M6275065-5: 11.06.03.01V; 11.06.03.02V; 11.06.03.03V; 11.21.03.15; 12.01.03.25; 12.15.03.14; 12.18.03.07; 01.16.04.09; 01.08.04.10; 01.20.04.10; 12.15.03.14; 02.04.04.23; 01.21.04.24; 02.09.04.22; 02.23.04.07; 03.30.04.13; 03.22.04.10; 05.04.04.08; 05.14.04.04; 05.26.04.09; 06.02.04.07; 06.04.04.15; 06.17.04.12; 07.07.04.11; 07.07.04.12; 07.20.04.14; 07.30.04.03; and 08.03.04.06

Product code JCX

K032310Class IIMini V.a.c., V.a.c. Freedom, V.a.c. AtsKinetic Concepts, Inc. / cleared 2003-10-10

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)