Device recall
Z-2900-2026: GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504…
FDA device recall · Class II · Instrumentation Laboratory
Key facts
| Recall number (Z-number) | Z-2900-2026 |
|---|---|
| Recall event | 99128 |
| Product | GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A |
| Product code | CHL |
| Recalling firm | Instrumentation Laboratory |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203790 |
| FEI number | 1217183 |
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