Device recall
Z-1377-2019: Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in…
FDA device recall · Class II · Remel Inc
Key facts
| Recall number (Z-number) | Z-1377-2019 |
|---|---|
| Recall event | 82677 |
| Product | Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes |
| Product code | JSG |
| Recalling firm | Remel Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| FEI number | 1924669 |
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