Z-2717-2014Class II

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

Name: Z-2717-2014 CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Creator: KCI USA, Inc.
Published: 2014-05-19
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2014-05-19 / Terminated / root cause: design

FDA source

KCI USA, Inc. began a recall of CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 on 2014-05-19. FDA classified it as Class II and gives the reason as "Blade can shift during shipping which makes the product ineffective". 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-2717-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Posted: 2014-09-29
Terminated: 2015-09-18
Recalling firm: KCI USA, Inc.
Product: CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Product code: GFD Dermatome
Reason for recall: Blade can shift during shipping which makes the product ineffective.
Root cause tag: design
FDA root cause: Device Design
Action: KCI sent an Urgent - Voluntary Medical Device Field Notification letter dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is sending Field Notifications to affected customers instructing them to complete appropriate actions. Option I: Contact your local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected harvester(s). Option 2: If you prefer, you may re-set the blade after removal from the packaging by gently tapping the curved end of the harvester against the palm of your hand, as shown in Figure 3, until the blade is no longer visible in the harvester top plate, as shown in Figure 4.
Quantity in commerce: 1,331 units
Distribution: US nationwide Distribution
Product codes and lots: Part number CT-H25 with the following lot numbers: 3244680000, 3446210000, 3246280000, 3246480000, 3246490000, 3246970000, 3247020000, 3247030000, 3247130000, 3247440000, 3247670000, 3247680000, 3247980000, 3248070000, 3248200000, 3248300000, 3249120000, 3249130000, 3249140000, 3249150000, 3249160000. Part number CT-H50 with the following lot numbers: 324782, 324796, 324797, 3245120000, 3245670000, 3245680000, 3246270000, 3246490000, 3246690000, 3246700000, 3246940000, 3246980000, 3247140000, 3247160000, 3247170000, 3247250000, 3247310000, 3247470000, 324780000, 3247810000, 3247820000, 3247960000, 3247970000, 3248080000, 3248190000, 3248230000, 3248300000, 3248380000, 3248960000, 3248970000, 3248980000, 3248990000, 3249000000, 3249010000, 3249020000, 3249030000, 3249040000, 3249050000, 3249060000, 3249070000, 3249080000, 3249090000, 3249100000, 3249110000, 3249390000, 3249580000.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2717-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2717-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-29

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)