FDA Medical Device Recalls (openFDA)
Kinetic Concepts, Inc: 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
- Recall number
- Z-0038-05
- Recalling firm
- Kinetic Concepts, 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
- Status
- Terminated
- Initiated
- 2004-09-21
- Posted
- 2004-10-22
- Terminated
- 2005-06-07
- Reason
- The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.
- Root cause
- Other
- Action
- The firm initiated the recall by letter and phone calls on September 21, 2004.
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K032310"]
- PMA numbers
- not on file
- Product code
- JCX
- Firm FEI
- 1625774
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28