Device 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
Z-2171-2017
Product summary
- Firm
- KCI USA, INC.
- Event
- Event 77159
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,385 cases
- Official record key
device-enforcement:Z-2171-2017
Official wording
Reason: Potential sterile barrier breach
Code information: 51020446, 51020448, 51020449, 51020750, 51020751, 51020752, 51020753, 51020856, 51021472, 51021936, 51021938, 51021939, 51021940, 51022283, 51022440, 51022441, 51022719
Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia
Derived failure modes
-
Sterility assurance
sterile barrier breach