Device recall
Z-0104-2018: HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx…
FDA device recall · Class II · Terumo BCT, Inc.
Key facts
| Recall number (Z-number) | Z-0104-2018 |
|---|---|
| Recall event | 78307 |
| Product | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO |
| Product code | JQC |
| Recalling firm | Terumo BCT, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| 510(k) numbers | K052925, K103340, K991430 |
| FEI number | 1000117351 |
At a glance
- 1–9 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