Device recall
Z-1331-2021: Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an…
FDA device recall · Class I · Tenacore LLC
Key facts
| Recall number (Z-number) | Z-1331-2021 |
|---|---|
| Recall event | 87470 |
| Product | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part |
| Product code | FRN |
| Recalling firm | Tenacore LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 5, 2024 |
| 510(k) numbers | K133532 |
| FEI number | 3008403701 |
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