FDA Device recall Z-0933-2015
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc
- FDA Device
- Class II
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class II recall of CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc by Kci Usa, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0933-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-19 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kci Usa |
| Distribution | US |
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.
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.
Identifiers
| code_info | CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3…CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0933-2015%22
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