Device recall
Z-2204-2021: Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical…
FDA device recall · Class I · BioMedical Equipment Service Co (BMES)
Key facts
| Recall number (Z-number) | Z-2204-2021 |
|---|---|
| Recall event | 88170 |
| Product | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410 |
| Product code | FRN |
| Recalling firm | BioMedical Equipment Service Co (BMES) |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 22, 2024 |
| 510(k) numbers | K133532 |
| FEI number | 3009548038 |
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