CAREstream ProNox Nitrous Oxide Delivery Systems Recalled for High Gas Levels
CAREstream Medical LLC is recalling 919 ProNox Nitrous Oxide Delivery Systems because two units delivered higher levels of nitrous oxide than specified during routine testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that delivered gas levels outside of specification, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
CAREstream Medical LLC is recalling 919 units of the CAREstream ProNox Nitrous Oxide Delivery System. The affected products include various configurations such as the Pro-Nox Mixer, Complete Hospital Roll Stand System, and Hospital System Wall Mount. These devices are used to deliver oxygen and nitrous oxide mixtures.
The recall was initiated after two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing. The source text does not report any illnesses or injuries associated with this issue.
The recalled units were distributed domestically across numerous US states and internationally to Canada and Morocco. Users of these systems should contact CAREstream Medical LLC for further instructions on how to address the potential deviation from specifications.
The recalled product
- 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…
- Manufacturer
- CAREstream Medical LLC
- Hazard
- Affected units
- 919
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item Number CMI-0100-PNX-xxx
Distribution
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