Z-0020-2013Class I

Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664...

Name: Z-0020-2013 Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664...
Creator: Accutron Inc
Published: 2012-04-29
License: https://open.fda.gov/license/

Accutron Inc / initiated 2012-04-29 / Terminated / root cause: design

FDA source

Accutron Inc began a recall of Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740... on 2012-04-29. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0020-2013
Classification: Class I
Status: Terminated
Initiated: 2012-04-29
Posted: 2012-10-09
Terminated: 2013-02-01
Recalling firm: Accutron Inc
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.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Accutron sent an Urgent Advisory Notice letter dated April 6, 2012 to all their customers who purchased the Ultra PC% Cabinet Mount Flowmeter. The letter informed the customers of the problem identified and actions to be taken. Customers were instructed to discontinue use or to continue use of the device only with extreme care until a replacement can be installed. Extreme care includes the use of the titration method for nitrous oxide administration coupled with close monitoring of both the patient and the actual gas flow through the flowtubes. For question contact Accutron at (800) 531-2221 or by email at [email protected].
Quantity in commerce: 220 units total
Distribution: US Nationwide Distribution
Product codes and lots: Lot # 73656, 74139, 75209, 74689, 75515, 74858.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0020-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0017-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09
Z-0018-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09
Z-0019-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09
Z-0020-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09

Product code BSZ

K052335Class IIAnalgesia Gas Machine, Model Digital UltraAccutron, Inc. / cleared 2005-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)