Device recall
Z-1258-2021: ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical…
FDA device recall · Class I · Smisson-Cartledge Biomedical, LLC
Key facts
| Recall number (Z-number) | Z-1258-2021 |
|---|---|
| Recall event | 86808 |
| Product | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or… |
| Product code | LGZ |
| Recalling firm | Smisson-Cartledge Biomedical, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 26, 2024 |
| 510(k) numbers | K052055 |
| FEI number | 3006158088 |
At a glance
- 1–9 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