Recall Z-2171-2017— KCI USA, INC.

Name: FDA recall Z-2171-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Class II · Terminated

Class II FDA medical device recall by KCI USA, INC., initiated 2017-04-28, terminated 2018-02-01. It names one FDA 510(k) clearance: K063740. 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. Reason: Potential sterile barrier breach.

Recalling firm: KCI USA, INC.
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Terminated: 2018-02-01
Firm location: San Antonio, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K063740 — V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766Kci USA, Inc.·cleared 2007-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Potential sterile barrier breach

Data sourced from openFDA. This site is unofficial and independent of the FDA.