Device recall
Z-0257-2018: Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a)…
FDA device recall · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-0257-2018 |
|---|---|
| Recall event | 78546 |
| Product | Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692 74102 75490 74432-01 75477 75478 75104-02 75104-03 75477-01 75037 75973 75308-01 75688 70571-06 75114-01 72755 73306 71180-01… |
| Product code | DTL |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2019 |
| 510(k) numbers | K820297 |
| FEI number | 3000204839 |
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