Device recall
Z-0068-2021: Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and…
FDA device recall · Class II · Medline Industries Inc
Key facts
| Recall number (Z-number) | Z-0068-2021 |
|---|---|
| Recall event | 86503 |
| Product | Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment… |
| Product code | OEQ |
| Recalling firm | Medline Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2021 |
| FEI number | 1417592 |
At a glance
- None 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