Device recall
Z-0075-2018: HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO…
FDA device recall · Class II · Terumo BCT, Inc.
Key facts
| Recall number (Z-number) | Z-0075-2018 |
|---|---|
| Recall event | 78309 |
| Product | HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem… |
| Product code | FMF |
| Recalling firm | Terumo BCT, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2021 |
| 510(k) numbers | K043261 |
| FEI number | 1000117351 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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