FDA Medical Device Recalls (openFDA)
KCI USA, INC.: 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.
- Recall number
- Z-0933-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-11-19
- Posted
- 2015-01-07
- Terminated
- 2015-09-18
- 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.
- 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
- 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.
- Lot, serial or model codes
- CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFD
- Firm FEI
- 3009897021
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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