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U.S. Department of Health and Human Services

Class 1 Device Recall CM Flowmeter Pkg H

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 Class 1 Device Recall CM Flowmeter Pkg Hsee related information
Date Initiated by FirmApril 29, 2012
Date PostedOctober 09, 2012
Recall Status1 Terminated 3 on February 01, 2013
Recall NumberZ-0019-2013
Recall Event ID 63174
510(K)NumberK052335 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductCM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Code Information Lot # 75285 
Recalling Firm/
Manufacturer		 Accutron Inc
1733 W Parkside Ln
Phoenix AZ 85027-1382
For Additional Information Contact
623-780-2020
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionAccutron 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 jheadrick@accutron-inc.com.
Quantity in Commerce220 units total
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BSZ
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