FDA Device Recall Z-0019-2013: Accutron Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-2013.

Recall Res Number

Z-0019-2013

Recalling Firm / Manufacturer

Accutron Inc

FEI Number

2020813

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-04-29

Date Posted

2012-10-09

Date Terminated

2013-02-01

Product Code

BSZ

Event Number

63174

Product Quantity

220 units total

Product Description CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.

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.

Action Details 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 jheadrick@accutron-inc.com.

Distribution Pattern US Nationwide Distribution

Code Information / Serial Numbers Lot # 75285

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Medical Device Recall: Z-0019-2013

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer