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Recall Observatory FDA recall evidence

Device product

Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.

Z-0020-2013

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-0020-2013

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 # 73656, 74139, 75209, 74689, 75515, 74858.

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.