Class 2 Device Recall Negative Pressure Wound Therapy Systems

• Date Initiated by Firm: April 28, 2017
• Create Date: May 30, 2017
• Recall Status: Terminated on February 01, 2018
• Recall Number: Z-2171-2017
• Recall Event ID: 77159
• 510(K)Number: K063740
• Product Classification: negative pressure wound therapy Powered suction pump - Product Code OMP
• Product: 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister
• Code Information: 51020446, 51020448, 51020449, 51020750, 51020751, 51020752, 51020753, 51020856, 51021472, 51021936, 51021938, 51021939, 51021940, 51022283, 51022440, 51022441, 51022719
• Recalling Firm/ Manufacturer: KCI USA, INC.; 12930 W Interstate 10; San Antonio TX 78249-2248
• For Additional Information Contact: KCI Representative; 210-515-4108
• Manufacturer Reason for Recall: Potential sterile barrier breach
• FDA Determined Cause: Packaging process control
• Action: KCI sent an Urgent Voluntary Medical Device Field Notification letter to all affected consignees on April 28, 2017. KCI will monitor return of the Customer Reconciliation Forms to ensure compliance with the Field Notification. Customers were instructed locate and quarantine any of the affected product, complete Acknowledgement form and email to RegulatoryCompliance@acelity.com or fax to 210-255-6727. Customers with questions were advised to contact their local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected product.. For questions regarding this recall call 210-515-4108.
• Quantity in Commerce: 5,385 cases
• Distribution: Worldwide Distribution - US (nationwide) Internationally to Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia
• 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.

• 510(K) Database: 510(K)s with Product Code = OMP