FDA Device recall Z-2887-2018
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian
- FDA Device
- Class II
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian by Carestream Medical, citing two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2887-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-15 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carestream Medical |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
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. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
Reason
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
Identifiers
| code_info | Item Number CMI-0100-PNX-xxx |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2887-2018%22
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