Device recall
Z-1912-2026: PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI…
FDA device recall · Class II · ARROW INTERNATIONAL, LLC
Key facts
| Recall number (Z-number) | Z-1912-2026 |
|---|---|
| Recall event | 98618 |
| Product | PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow percutaneous sheath introducer permits venous access and catheter introduction to the central circulation. |
| Product code | OFL |
| Recalling firm | ARROW INTERNATIONAL, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3013162291 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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