# FDA recall Z-2887-2018

> **CAREstream Medical LLC** · Class II · device recall initiated 2018-05-15.

## 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 for recall

Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.

## Distribution

Domestic 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.      International Distribution:  Canada and Morocco.

## Key facts

- **Recall number:** Z-2887-2018
- **Recalling firm:** CAREstream Medical LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-15
- **Report date:** 2018-08-29
- **Termination date:** 2025-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Altamonte Springs, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2887-2018

## Citation

> AI Analytics. FDA recall Z-2887-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2887-2018. Source: US FDA. Licensed CC0.

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