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Recall Observatory FDA recall evidence

Device product

CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.

Z-0019-2013

April 29, 2012

Class I

Product summary

Firm
Accutron Inc
Event
Event 63174
Status
Terminated
Classification
Class I
Quantity
220 units total
Official record key
device-enforcement:Z-0019-2013

Official wording

Reason: 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.

Code information: Lot # 75285

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.