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Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Accutron Ultra PC% Cabinet Mount Flowmeters

08 Oct 2012

The United States Food and Drug Administration (FDA) has posted a Firm Press Release concerning Ultra PC% Cabinet Mount Flowmeters, manufactured by Accutron Inc.

Accutron, Inc., issued a nationwide recall of two hundred and six (206) Ultra PC% Cabinet Mount Flowmeters. Some of the flowmeters have been found to release Nitrous Oxide gas when the Oxygen is turned off. A flowmeter releasing Nitrous Oxide gas without Oxygen could potentially lead to serious injuries like brain damage in patients. Only two complaints have been received regarding the above described flowmeter defect. No injuries have been reported to date.

The recall includes the following product model numbers:

  • 27025 Flowmeter, CM Assy
  • 36600-NS Ultra PC% Cabinet Mount Package G, No Shut offs: 36800-NS Ultra PC% Cabinet Mount Package H, No Shut offs
  • 36600 Ultra PC% Cabinet Mount package G
  • 36700 CM Flowmeter Package H
  • 5000 Newport Flowmeter System
  • 36800 Ultra PC% cabinet Mount package H
  • 31970 Flowmeter CM

Consumers who have these flowmeters which are being recalled should stop using and return these flowmeters to Accutron for free replacement.

For details, please refer to the following FDA website:
http://www.fda.gov/Safety/Recalls/ucm322799.htm.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 8 October 2012

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