Device recall
Z-0933-2015: CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only…
FDA device recall · Class II · KCI USA, INC.
Key facts
| Recall number (Z-number) | Z-0933-2015 |
|---|---|
| Recall event | 69961 |
| 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 |
| Recalling firm | KCI USA, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2015 |
| FEI number | 3009897021 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database