Device recall
Z-0318-2021: 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO…
FDA device recall · Class II · OriGen Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0318-2021 |
|---|---|
| Recall event | 85124 |
| Product | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only |
| Product code | KFM |
| Recalling firm | OriGen Biomedical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 14, 2021 |
| 510(k) numbers | K170029 |
| FEI number | 1000160256 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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