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Accutron, Inc. Issues Nationwide Voluntary Recall of Flowmeters


10/9/2012 8:38:58 AM

October 4, 2012 - Accutron, Inc. Issues 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.

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

The recall includes the following product model numbers and associated serial numbers:

27025 Flowmeter, CM Assy: See attached Serial Numbers.

36600-NS Ultra PC% Cabinet Mount Package G, No Shut offs: See attached Serial Numbers.

36800-NS Ultra PC% Cabinet Mount Package H, No Shut offs: See attached Serial Numbers.

36600 Ultra PC% Cabinet Mount package G: See attached Serial Numbers.

36700 CM Flowmeter Package H: See attached Serial Numbers.

5000 Newport Flowmeter System: see attached Serial Numbers.

36800 Ultra PC% cabinet Mount package H: See attached Serial Numbers.

31970 Flowmeter CM: See attached Serial Numbers.

The firm voluntarily recalled the products after learning through two customer complaints that the flowmeter was flowing Nitrous Oxide gas without any Oxygen gas flow. FDA has been apprised of this action.

Only two complaints have been received regarding the above described flowmeter defect. No injuries have been reported to date.

The product was distributed through courier services to various dealers located across the United States. The product can be identified using the serial number.

Accutron, Inc. is notifying its distributors and customers by mailing Advisory Notice and is arranging for return and replacement of all recalled products.

Consumers with questions may contact the company at 1-800- 531-2221.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/MedWatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: hwww.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178



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