KCI CelluTome Epidermal Harvesting System Harvester Blades May Drift During Shipping
KCI USA is recalling CelluTome Epidermal Harvesting System Harvesters because blades may drift and protrude from the top plate during shipping.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sharp blades protruding) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
KCI USA, Inc. is recalling the CelluTome Epidermal Harvesting System Harvester (5.0 CM), sterile, prescription-only, part numbers CT-H50 and CT-H25. The device is intended to reproducibly cut a thin skin graft for autologous skin grafting.
The recall was initiated after reports that, in a small number of cases, the harvester blades have the potential to drift during shipping. This drift could cause the blades to prematurely protrude into the openings of the harvester top plate.
The affected units were distributed worldwide, including nationwide in the United States and internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Israel, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey, UAE, and the United Kingdom. The specific lot numbers affected are CT-H25: 3249980000, 3249990000, 3250010000, 2537872, 2556866; and CT-H50: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871. Users should check their device part numbers and lot numbers against this list and contact KCI USA for further instructions.
The recalled product
- 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
- KCI USA, INC.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- CT-H25 lot numbers: 3249980000
- 3249990000
- 3250010000
- 2537872
- 2556866
- CT-H50 lot numbers: 3249660000
- 3249840000
- 3250050000
- 2498886
- 2510874
- 2537879
- 2545871
Distribution
Distributed nationwide across the United States.
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