Device recall
Z-0900-2022: LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product#…
FDA device recall · Class II · Kaneka America Corp
Key facts
| Recall number (Z-number) | Z-0900-2022 |
|---|---|
| Recall event | 89735 |
| Product | LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786… |
| Product code | MMY |
| Recalling firm | Kaneka America Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2024 |
| PMA numbers | P910018 |
| FEI number | 2435151 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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