FDA-Device2014-10-08Class II

CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

KCI USA, Inc.
Hazard

Blade can shift during shipping which makes the product ineffective.

Sold states
US nationwide Distribution
Affected count
1,331 units
Manufactured in
6203 Farinon Dr, N/A, San Antonio, TX, United States
Products
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2717-2014

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