Home / Recalls / KCI USA, INC. / Z-2171-2017

Z-2171-2017 Class II Terminated

Recalled by KCI USA, INC. — San Antonio, TX

Recall Details

Product Type
Devices
Report Date
June 7, 2017
Initiation Date
April 28, 2017
Termination Date
February 1, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,385 cases

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

Distribution Pattern

Worldwide Distribution - US (nationwide) Internationally to Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia

Code Information

51020446, 51020448, 51020449, 51020750, 51020751, 51020752, 51020753, 51020856, 51021472, 51021936, 51021938, 51021939, 51021940, 51022283, 51022440, 51022441, 51022719

Other recalls by KCI USA, INC.

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  • Z-0507-2025 Class II — V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Nega (November 5, 2024)
  • Z-2542-2020 Class II — ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN (June 8, 2020)
  • Z-0600-2016 Class II — ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the appli (November 25, 2015)
  • Z-0933-2015 Class II — CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manu (November 19, 2014)
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  • Z-2717-2014 Class II — CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 (May 19, 2014)
  • Z-1135-2014 Class II — PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incis (January 30, 2014)
  • Z-1137-2014 Class II — PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Manage (January 30, 2014)