CAREstream recalls specific nitrous oxide delivery systems that may deliver higher nitrous oxide levels than specified, potentially causing safety risks during medical use. Affected models include Canadian and hospital versions with item numbers starting CMI-0100-PNX.
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
CAREstream is recalling certain nitrous oxide delivery systems that may deliver higher levels of nitrous oxide than intended during routine testing. This could pose safety risks for patients receiving medical treatment using these devices.
The recalled systems were reported to deliver higher levels of nitrous oxide than specified during routine testing. Nitrous oxide is a medical gas used for pain relief and sedation, so excessive levels could cause unintended medical effects or safety risks during treatment.
Medical facilities using the recalled nitrous oxide delivery systems are most at risk. Patients receiving medical treatment with these systems could be affected if the higher nitrous oxide levels cause unintended medical effects.
Check for item numbers starting with CMI-0100-PNX on the device label. The affected models include Canadian versions and hospital systems with specific suffixes like -HS, -NO2H, -NHS, and -PS.
Look for item numbers starting with CMI-0100-PNX on the device label to identify if it is affected.
The affected models include CMI-0100 PNX (Pro-Nox Mixer), CMI-0100-PNX-HS (Pro-Nox Complete Hospital Roll Stand System), and other variants with item numbers starting with CMI-0100-PNX.
The recall is due to reports that these nitrous oxide delivery systems may deliver higher levels of nitrous oxide than specified during routine testing, which could pose safety risks during medical use.
No immediate stop is required; the recall asks for checking the device label to identify affected models. However, medical facilities should monitor the situation and follow any additional guidance.
We’ve drafted a message you can send CAREstream to request your refund or repair — edit it as you like.
Subject: Recall Z-2887-2018 — CAREstream CAREstream Hello, I own a CAREstream that is covered by recall Z-2887-2018 from CAREstream. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.