Device recall
Z-1314-2018: Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte…
FDA device recall · Class II · Terumo Cardiovascular Systems Corp
Key facts
| Recall number (Z-number) | Z-1314-2018 |
|---|---|
| Recall event | 79524 |
| Product | Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filter for Exhacorporeal Service is indicated for use only in the exhacorporeal… |
| Product code | OEZ |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2019 |
| FEI number | 1000149028 |
At a glance
- None 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