Device recall
Z-0001-2024: Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC…
FDA device recall · Class I · ARROW INTERNATIONAL Inc.
Key facts
| Recall number (Z-number) | Z-0001-2024 |
|---|---|
| Recall event | 93014 |
| Product | Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter |
| Product code | LJS |
| Recalling firm | ARROW INTERNATIONAL Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K153487 |
| FEI number | 3013162291 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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