FDA-Device2014-10-22Class II
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.
KCI USA, Inc.
Hazard
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.
Sold states
The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.
Affected count
1090 pouches (109 boxes)
Manufactured in
6203 Farinon Dr, N/A, San Antonio, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2015Don't want to check this manually?
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