Device recall
Z-1544-2021: Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with…
FDA device recall · Class I · Infusion Pump Repair
Key facts
| Recall number (Z-number) | Z-1544-2021 |
|---|---|
| Recall event | 87657 |
| Product | Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part |
| Product code | FRN |
| Recalling firm | Infusion Pump Repair |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K133532 |
| FEI number | 3011655432 |
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