FDAFDA · Food and drugs·Recall number Z-0019-2013
CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Published October 17, 2012 · Recall initiated: April 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Accutron Inc
- Distributor
- US Nationwide Distribution
- Lot
- Lot # 75285
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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