Home / Recalls / KCI USA, INC. / Z-1135-2014

Z-1135-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
March 12, 2014
Initiation Date
January 30, 2014
Termination Date
April 6, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,850 units total

Product Description

PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is 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.

Reason for Recall

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Distribution Pattern

USA Nationwide Distribution

Code Information

Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890

Other recalls by KCI USA, INC.

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  • Z-1175-2025 Class II — 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus D (January 17, 2025)
  • 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-2171-2017 Class II — 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part (April 28, 2017)
  • 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)
  • Z-0070-2015 Class II — V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and m (September 18, 2014)
  • Z-2717-2014 Class II — CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 (May 19, 2014)
  • Z-1141-2014 Class II — PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Prod (January 30, 2014)