Device recall
Z-1367-2021: Consist of a distal connection mechanism (either standard Terumo Ball Quick…
FDA device recall · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-1367-2021 |
|---|---|
| Recall event | 87504 |
| Product | Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor. |
| Product code | MWS |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2021 |
| FEI number | 3000204839 |
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