Device recall
Z-1100-2026: Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1…
FDA device recall · Class II · ICU Medical Inc.
Key facts
| Recall number (Z-number) | Z-1100-2026 |
|---|---|
| Recall event | 98168 |
| Product | Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG |
| Product code | JKA |
| Recalling firm | ICU Medical Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K952516 |
| FEI number | 3012307300 |
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