Device recall
Z-2137-2018: remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH…
FDA device recall · Class II · Thermo Fisher
Key facts
| Recall number (Z-number) | Z-2137-2018 |
|---|---|
| Recall event | 80068 |
| Product | remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin). |
| Product code | JTZ |
| Recalling firm | Thermo Fisher |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 19, 2018 |
| 510(k) numbers | K850291 |
| FEI number | 1924669 |
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