Home / Recalls / KCI USA, INC. / Z-0933-2015

Z-0933-2015 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
January 14, 2015
Initiation Date
November 19, 2014
Termination Date
September 18, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,139/5 Packs

Product Description

CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.

Reason for Recall

KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.

Distribution Pattern

Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE, and United Kingdom.

Code Information

CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871

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  • 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-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)