Device recall
Z-0796-2025: SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13"…
FDA device recall · Class II · Med Michigan Holding Llc
Key facts
| Recall number (Z-number) | Z-0796-2025 |
|---|---|
| Recall event | 95889 |
| Product | SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field. |
| Product code | GCX |
| Recalling firm | Med Michigan Holding Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K971022 |
| FEI number | 3017540705 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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