Reported Aug 29, 2018 · Terminated
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following
CAREstream Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CAREstream Medical LLC · 774 Northlake Blvd Ste 1016 · Altamonte Springs, FL · 32701-6709
Is this the product you have?
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following
7 of 7 products
| Model / number | Product as published |
|---|---|
| — | CMI-0100 PNX, Pro-Nox Mixer - Canadian |
| — | CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System |
X-HS-NO2H | CMI-0100- , Pro-Nox Hospital System without Oxygen Regulator |
| — | CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger |
| — | CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital) |
| — | CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger |
| — | CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses |
- Lot codes and dates
- Item Number CMI-0100-PNX-xxx
- Amount recalled
- 919 Units Total
Where it was sold
Why it was recalled
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
This product could cause temporary or reversible health problems — stop using it.
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