Class 2 Device Recall Amvex Integrated Flowmeter

• Date Initiated by Firm: May 29, 2009
• Date Posted: August 21, 2009
• Recall Status: Terminated on August 19, 2011
• Recall Number: Z-1724-2009
• Recall Event ID: 52057
• Product Classification: Integrated Flowmeter - Product Code CCN
• Product: Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment.
• Code Information: All serial numbers shipped between 4/12/07 and 8/31/07. Serial numbers: FIA05076LF, FIA05078LF, FIA05086LF, FIA05089LF, FIA05090LF, FIA05091LF, FIA05173LF, FIA05174LF, FIA05175LF, FIA05176LF, FIA05177LF, FIA05178LF, FIA05179LF, FIA05180LF, FIA05181LF, FIA05182LF, FIA05183LF, FIA05184LF, FIA05186LF, FIA05187LF, FIA05188LF, FIA05189LF, FIA05190LF, FIA05191LF, FIA05192LF, FIA05193LF, FIA05194LF, FIA05195LF, FIA05196LF, FIA05197LF, FIA05198LF, FIA05200LF, FIA05201LF, FIA05202LF, FIA05203LF, FIA05204LF, FIA05205LF, FIA05206LF, FIA05207LF, FIA05208CF, FIA05208LF, IA05209LF, FIA05210LF, FIA05211LF, FIA05212LF, FIA05213LF, FIA05214LF, FIA05215LF, FIA05216LF, FIA05217LF, FIA05218LF, FIA05219LF, FIA05220LF, FIA05221LF, FIA05222LF, FIA05223LF, FIA05224LF, FIA05226LF, FIA05229LF, FIA05230LF, FIA05231LF, FIA05233LF, FIA05234LF, FIA05236LF, FIA05237LF, FIA05238LF, FIA05239LF, FIA05240LF, FIA05241LF, FIA05242LF, FIA05243LF, FIA05244LF, FIA05245LF, FIA05246LF, FIA05247LF, FIA05248LF, FIA05249LF, FIA05250LF, FIA05251LF, FIA05252LF, FIA05253LF, FIA05254LF, 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FIA05432CG, FIA05433CG, FIA05434CG, FIA05435CG, FIA05436CG, FIA05437CG, FIA05439CG, FIA05440CG, FIA05442CG, FIA05443CG, FIA05444CG, FIA05445CG, FIA05446CG, FIA05447CG, FIA05448CG, FIA05449CG, FIA05450CG, FIA05451CG, FIA05452CG, FIA05453CG, FIA05455CG, FIA05456CG, FIA05457CG, FIA05458CG, FIA05459CG, FIA05460CG, FIA05461CG, FIA05462CG, FIA05463CG, FIA05464CG, FIA05465CG, FIA05466CG, FIA05467CG, FIA05468CG, FIA05469CG, FIA05470CG, FIA05471CG, FIA05472CG, FIA05473CG, FIA05474CG, FIA05476CG, FIA05477CG, FIA05478CG, FIA05479CG, FIA05480CG, FIA05481CG, FIA05482CG, FIA05483CG, FIA05484CG, FIA05485CG, FIA05486CG, FIA05487CG, FIA05488CG, FIA05489CG, FIA05490CG, FIA05491CG, FIA05492CG, FIA05493CG, FIA05494CG, FIA05495CG, FIA05496CG, FIA05497CG, FIA05498CG, FIA05499CG, FIA05500CG, FIA05502CG, FIA05503CG, FIA05504CG, FIA05505CG, FIA05506CG,,FIA05507CG, FIA05508CG, FIA05509CG, FIA05510CG, FIA05511CG, FIA05512CG, FIA05514CG, FIA05515CG, FIA05516CG, FIA05517CG, FIA05518CG, FIA05519CG, FIA05520CG, FIA05521CG, FIA05522CG, FIA05523CG, FIA05524CG, FIA05525CG, FIA05526CG, FIA05527CG, FIA05528CG, FIA05529CG, FIA05530CG, FIA05532CG, FIA05533CG, FIA05534CG, FIA05535CG, FIA05537CG, FIA05538CG, FIA05539CG, FIA05540CG, FIA05541CG, FIA05542CG, FIA05543CG, FIA05545CG, FIA05546CG, FIA05547CG, FIA05548CG, FIA05549CG, FIA05550CG, FIA05551CG, FIA05552CG, FIA05553CG, FIA05554CG, FIA05555CG, FIA05556CG, FIA05557CG, FIA05559CG, FIA05560CG, FIA05562CG, FIA05563CG, FIA05564CG, FIA05565CG, FIA05566CG, FIA05567CG, FIA05568CG, FIA05569CG, FIA05570CG, FIA05571CG, FIA05572CG, FIA05573CG, FIA05574CG, FIA05575CG, FIA05576CG, FIA05577CG, FIA05578CG, FIA05579CG, FIA05580CG, FIA05581CG, FIA05582CG, FIA05583CG, FIA05584CG, FIA05585CG, FIA05586CG, FIA05587CG, FIA05588CG, FIA05589CG, FIA05590CG, FIA05591CG, FIA05592CG, FIA05593CG, FIA05594CG, FIA05595CG, FIA05596CG, FIA05597CG, FIA05598CG, FIA05599CG, FIA05600CG, FIA05601CG, FIA05602CG, FIA05604CG, FIA05605CG, FIA05606CG, FIA05607CG, FIA05608CG, FIA05609CG, FIA05610CG, FIA05611CG, FIA05612CG, FIA05613CG, FIA05614CG, FIA05615CG, FIA05616CG, FIA05617CG, FIA05618CG, FIA05619CG, FIA05620CG, FIA05621CG, FIA05622CG, FIA05623CG, FIA05626CG, FIA05628CG, FIA05629CG, FIA05631CG, FIA05633CG, FIA05634CG, FIA05635CG, FIA05636CG, FIA05637CG, FIA05638CG, FIA05639CG, FIA05640CG, FIA05641CG, FIA05642CG, FIA05643CG, FIA05644CG, FIA05645CG, FIA05646CG, FIA05647CG, FIA05649CG, FIA05650CG, FIA05651CG, FIA05652CG, FIA05653CG, FIA05654CG, FIA05655CG, FIA05656CG, FIA05657CG, FIA05659CG, FIA05660CG, FIA05661CG, FIA05662CG, FIA05663CG, FIA05664CG, FIA05665CG, FIA05666CG, FIA05667CG, FIA05669CG, FIA05670CG, FIA05671CG, FIA05672CG, FIA05673CG, FIA05674CG, FIA05675CG, FIA05678CG, FIA05679CG, FIA05680CG, FIA05681CG, FIA05686CG, FIA05687CG, FIA05690CG, FIA05694CG, FIA05695CG, FIA05698CG, FIA05699CG, FIA05700CG, FIA05701CG, FIA05702CG, FIA05703CG, FIA05704CG, FIA05705CG, FIA05706CG, FIA05708CG, FIA05712CG, FIA05713CG, FIA05714CG, FIA05715CG, FIA05717CG, FIA05718CG, FIA05719CG, FIA05720CG, FIA05721CG, FIA05722CG, FIA05723CG, FIA05725CG, FIA05726CG, FIA05728CG, FIA05731CG, FIA05732CG, FIA05733CG, FIA05734CG, FIA05736CG, FIA05744CG, FIA05745CG, FIA05746CG, FIA05747CG, FIA05749CG, FIA05751CG, FIA05752CG, FIA05755CG, FIA05759CG, FIA05760CG, FIA05765CG, FIA05767CG, FIA05771CG, FIA05774CG, FIA05775CG, FIA05776CG, FIA05779CG, FIA05781CG, FIA05783CG, FIA05784CG, FIA05785CG, FIA05786CG, FIA05789CG, FIA05790CG, FIA05792CG, FIA05806CG, FIA05807CG, FIA05808CG, FIA05810CG, FIA05811CG, FIA05812CG, FIA05814CG, FIA05815CG, FIA05816CG, FIA05817CG, FIA05820CG, FIA05821CG, FIA05822CG, FIA05823CG, FIA05826CG, FIA05832CG, FIA05833CG, FIA05834CG, FIA05836CG, FIA05837CG, FIA05838CG, FIA05839CG, FIA05840CG, FIA05841CG, FIA05842CG, FIA05844CG, FIA05845CG, FIA05846CG, FIA05847CG, FIA05848CG, FIA05849CG, FIA05850CG, FIA05851CG, FIA05853CG, FIA05854CG, FIA05855CG, FIA05856CG, FIA05861CG, FIA05862CG, FIA05863CG, FIA05864CG, FIA05865CG, FIA05866CG, FIA05868CG, FIA05869CG, FIA05870CG, FIA05875CG, FIA05876CG, FIA05878CG, FIA05882CG, FIA05883CG, FIA05884CG, FIA05885CG, FIA05950CG, FIA05984CG, FIA05988CG, FIA05991CG, FIA06039CG and FIA05058HG.
• FEI Number: 3003272769
• Recalling Firm/ Manufacturer: Amvex Corporation; 10-121 Granton Drive; Richmond Hill Canada
• For Additional Information Contact: 866-462-6839
• Manufacturer Reason for Recall: The affected flowmeters may have a damaged o-ring which may cause the flowmeter to deliver higher amounts of gas and or not be able to shut off fully.
• FDA Determined Cause: Employee error
• Action: An "Urgent: Medical Device Recall" letter dated May 29, 2009 was issued to the affected direct accounts on the same date, informing them that the Integrated Flowmeters shipped between April 12, 2007 and August 31, 2007 may experience damage to the o-ring which helps to control the flow of gas from the flowmeter portion of the outlet. Units with a damaged o-ring might deliver higher amounts of gas and/or not be able to shut off fully. The letter provided a list of the affected serial numbers, and asked the accounts to confirm that they have flowmeters from the recall time period. The accounts were provided with interim instructions to use the flowmeters during the replacement period, and were instructed to call an Amvex Corporation Representative at 1-866-462-6839 with at least one of the affected serial numbers and provide the number of units that need replacement. The Amvex Corporation will send new flowmeters for replacement, with instructions on how to replace, record the serial numbers and return the recalled units. If the accounts distributed the units, they were requested to forward the recall letter to the end users. The accounts were also requested to complete the enclosed reply sheet acknowledging receipt of the letter and fax it back to the Amvex Corporation at 1-905-764-7743. Direct questions to the Amvex Corporation by calling 1-866-462-6839.
• Quantity in Commerce: 1,424 units
• Distribution: Worldwide Distribution -- US (including Puerto Rico), Canada, Iran, Peru, Taiwan and Thailand.
• Total Product Life Cycle: TPLC 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.