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KCI USA, INC. recalls CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Numbe
Recalled January 14, 2015 · FDA recall Z-0933-2015 · KCI USA
Hazard
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. · FDA Class II
Units
1,139/5 Packs
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
KCI USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →