Device recall
Z-2873-2026: Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride…
FDA device recall · Class I · Spectra Medical Devices, Llc
Key facts
| Recall number (Z-number) | Z-2873-2026 |
|---|---|
| Recall event | 98777 |
| Product | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices. |
| Product code | NGT |
| Recalling firm | Spectra Medical Devices, Llc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K082689, K103740 |
| FEI number | 3000204727 |
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