FDA Medical Device Recalls (openFDA)
KCI USA, Inc.: V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
- Recall number
- Z-0070-2015
- Recalling firm
- KCI USA, Inc.
- Product
- V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
- Status
- Terminated
- Initiated
- 2014-09-18
- Posted
- 2014-10-15
- Terminated
- 2015-07-24
- Reason
- A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
- Root cause
- Error in labeling
- Action
- KCI will send a customer letter to each consignee notifying them of the issue, and to return the affected units.
- Quantity
- 1090 pouches (109 boxes)
- Distribution
- The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.
- Lot, serial or model codes
- Lot Number 50775911
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OMP
- Firm FEI
- 3005178245
- 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