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U.S. Department of Health and Human Services

Class 2 Device Recall V.A.C. GranuFoam Silver Dressing

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  Class 2 Device Recall V.A.C. GranuFoam Silver Dressing see related information
Date Initiated by Firm September 18, 2014
Date Posted October 15, 2014
Recall Status1 Terminated 3 on July 24, 2015
Recall Number Z-0070-2015
Recall Event ID 69368
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
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.
Code Information Lot Number 50775911
Recalling Firm/
Manufacturer		 KCI USA, Inc.
6203 Farinon Dr
San Antonio TX 78249-3441
For Additional Information Contact
210-255-6438
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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