Home / Recalls / KCI USA, INC. / Z-0600-2016

Z-0600-2016 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
January 13, 2016
Initiation Date
November 25, 2015
Termination Date
November 17, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,728 units

Product Description

ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.

Reason for Recall

There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.

Distribution Pattern

Japan and Australia

Code Information

Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture.

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  • Z-1176-2025 Class II — 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V. (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-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-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)