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U.S. Department of Health and Human Services

Class 2 Device Recall Negative Pressure Wound Therapy Systems

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  Class 2 Device Recall Negative Pressure Wound Therapy Systems see related information
Date Initiated by Firm April 28, 2017
Create Date May 30, 2017
Recall Status1 Terminated 3 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/
12930 W Interstate 10
San Antonio TX 78249-2248
For Additional Information Contact KCI Representative
Manufacturer Reason
for Recall
Potential sterile barrier breach
FDA Determined
Cause 2
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 and Original Applicant = KCI USA, INC.