Reported Oct 22, 2014 · Terminated

V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring…

KCI USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: KCI USA, Inc. · 6203 Farinon Dr · San Antonio, TX · 78249-3441

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot Number 50775911
Amount recalled
1090 pouches (109 boxes)

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 24, 2015 · Data as of Sep 19, 5:28 PM UTC

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