Device recall
Z-0154-2026: IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off)…
FDA device recall · Class I · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0154-2026 |
|---|---|
| Recall event | 97698 |
| Product | IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext… |
| Product code | FMG |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K964435 |
| FEI number | 2025816 |
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