Device recall
Z-1651-2021: Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys…
FDA device recall · Class I · The Biomed Guys
Key facts
| Recall number (Z-number) | Z-1651-2021 |
|---|---|
| Recall event | 87768 |
| Product | Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel. |
| Product code | FRN |
| Recalling firm | The Biomed Guys |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K133532 |
| FEI number | 3018685909 |
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