Device recall
Z-0619-2019: SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123…
FDA device recall · Class II · ICU Medical Inc
Key facts
| Recall number (Z-number) | Z-0619-2019 |
|---|---|
| Recall event | 81615 |
| Product | SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems. |
| Product code | MRZ |
| Recalling firm | ICU Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2020 |
| 510(k) numbers | K171346 |
| FEI number | 3013319212 |
At a glance
- 1–9 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