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.
FDA Recall Z-0070-2015 · Posted 2014-10-15
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Recalling FirmKCI USA, Inc.
Recall StatusTerminated
Product CodeOMP
Date Initiated2014-09-18
Date Terminated2015-07-24
Product Quantity1090 pouches (109 boxes)
Reason for Recall
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.
Firm Action
KCI will send a customer letter to each consignee notifying them of the issue, and to return the affected units.
Root Cause
Error in labeling
Distribution Pattern
The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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