FDA Enforcement Class II Terminated

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

Recall: Z-2887-2018 · Reported August 29, 2018

Enforcement

Recall Number: Z-2887-2018
Event ID: 80340
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: CAREstream Medical LLC
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: August 29, 2018
Initiation Date: May 15, 2018
Classification Date: August 22, 2018
Termination Date: December 17, 2025
Address: 774 Northlake Blvd Ste 1016, Altamonte Springs, FL, 32701-6709, United States

Description

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.

Code Info

Item Number CMI-0100-PNX-xxx

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.

Quantity

919 Units Total