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FDAFDA · Food and drugs·Recall number Z-2171-2017

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

Published June 7, 2017 · Recall initiated: April 28, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potential sterile barrier breach

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
KCI USA, INC.
Distributor
Worldwide Distribution - US (nationwide) Internationally to Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia
Lot
51020446, 51020448, 51020449, 51020750, 51020751, 51020752, 51020753, 51020856, 51021472, 51021936, 51021938, 51021939, 51021940, 51022283, 51022440, 51022441, 51022719
Risk classification
Class II
Area (FDA)
device
Country
United States

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