Device recall
Z-1407-2021: Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the…
FDA device recall · Class II · Medline Industries Inc
Key facts
| Recall number (Z-number) | Z-1407-2021 |
|---|---|
| Recall event | 87561 |
| Product | Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range. |
| Product code | JIN |
| Recalling firm | Medline Industries Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 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