Recall Z-0933-2015— KCI USA, INC.
Class II · Terminated
Class II FDA medical device recall by KCI USA, INC., initiated 2014-11-19, terminated 2015-09-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- KCI USA, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-19
- Terminated
- 2015-09-18
- Firm location
- San Antonio, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.