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

• Date Initiated by Firm: September 18, 2014
• Date Posted: October 15, 2014
• Recall Status: Terminated 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: 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.