Device recall
Z-2364-2026: Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1…
FDA device recall · Class I · ARROW INTERNATIONAL, LLC
Key facts
| Recall number (Z-number) | Z-2364-2026 |
|---|---|
| Recall event | 98793 |
| Product | Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK… |
| Product code | CAZ |
| Recalling firm | ARROW INTERNATIONAL, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K001587, K122027, K801912, K884552 |
| FEI number | 3013162291 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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