Device recall
Z-2887-2018: CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a…
FDA device recall · Class II · CAREstream Medical LLC
Key facts
| Recall number (Z-number) | Z-2887-2018 |
|---|---|
| Recall event | 80340 |
| Product | CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d… |
| Product code | BZR |
| Recalling firm | CAREstream Medical LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2025 |
| 510(k) numbers | K113687 |
| FEI number | 3010396502 |
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