Home / Recalls / KCI USA, INC. / Z-0933-2015

Z-0933-2015 Class II Terminated

Recalled by KCI USA, INC. — San Antonio, TX

FDA device recall Z-0933-2015 was initiated by KCI USA, INC. on November 19, 2014 and is designated Class II. 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 co… The recall status is terminated (terminated September 18, 2015). Affected quantity: 1,139/5 Packs.

Recall Details

Product Type: Devices
Report Date: January 14, 2015
Initiation Date: November 19, 2014
Termination Date: September 18, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,139/5 Packs

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.

Distribution Pattern

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.

Code Information

CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871

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