CLASS I Device recall · Reported 17 Oct 2012 · FDA Enforcement Report
CM Flowmeter Pkg H recalled by Accutron
Accutron is recalling CM Flowmeter Pkg H, distributed nationwide in the US. The recall was initiated on 29 Apr 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0019-2013
- FDA event ID
- 63174
- Recalling firm
- Accutron, Phoenix, AZ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Apr 2012
- FDA classified
- 9 Oct 2012
- Reported
- 17 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Apr 2012 | Recall initiated by company | |
| 9 Oct 2012 | Classified by FDA | +163 days |
| 17 Oct 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Product as listed by the FDA
CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is CM Flowmeter Pkg H recalled?
Yes. Accutron recalled CM Flowmeter Pkg H on 29 Apr 2012. The recall is Class I and its status is Terminated. Recall number Z-0019-2013.
Why was it recalled?
Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Which lots are affected?
Lot # 75285
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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