Device recall
Z-0628-2022: 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF…
FDA device recall · Class I · TELEFLEX MEDICAL INC
Key facts
| Recall number (Z-number) | Z-0628-2022 |
|---|---|
| Recall event | 89390 |
| Product | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow… |
| Product code | QEW |
| Recalling firm | TELEFLEX MEDICAL INC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 11, 2024 |
| 510(k) numbers | K011056 |
| FEI number | 3005747797 |
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