Z-0933-2015Class II

CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc...

Name: Z-0933-2015 CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc...
Creator: Kci USA, Inc.
Published: 2014-11-19
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2014-11-19 / Terminated / root cause: design

FDA source

KCI USA, INC. began a recall of 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... on 2014-11-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0933-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Posted: 2015-01-07
Terminated: 2015-09-18
Recalling firm: KCI USA, Inc.
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.
Product code: GFD Dermatome
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.
Root cause tag: design
FDA root cause: Device Design
Action: KCI sent an Urgent - Voluntary Medical Device Field Notification letter to all affected consignees on December 8, 2014. The letter notified the customer of the issue, and provided instructions to inspect their harvester prior to use. If blade drift is identified, instructionswere provided to the customer to either return the device to KCI, or if they wish, how to reset the blade prior to use. The letter instructs the customer to respond to the recall notifcation by returning the product reconciliation form attached the letter. Follow-up notifcations will be send to non-responding consignees. Consignees with questions were instructed to contact their local KCI Representative or Customer Technical Service Center at 1-800-275-4524 and select option 3. For questions regarding this recall call 210-515-4108.
Quantity in commerce: 1,139/5 Packs
Distribution: 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.
Product codes and lots: CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0933-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0933-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07

Product code GFD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)