FDA Medical Device Recalls (openFDA)
KCI USA, Inc.: CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
- Recall number
- Z-2717-2014
- Recalling firm
- KCI USA, Inc.
- Product
- CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
- Status
- Terminated
- Initiated
- 2014-05-19
- Posted
- 2014-09-29
- Terminated
- 2015-09-18
- Reason
- Blade can shift during shipping which makes the product ineffective.
- 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
- 1,331 units
- Distribution
- US nationwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFD
- Firm FEI
- 3005178245
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28