FDAFDA · Food and drugs·Recall number Z-0933-2015
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.
Published January 14, 2015 · Recall initiated: November 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- KCI USA, INC.
- Distributor
- 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.
- Lot
- CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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