CORE

All codes distributed from February 2008 through May 2011

Nationwide Distribution

ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka || Surgical gloves

Models KKB5022-21US, serial numbers 010390894401, 010390894402, 010390894403, 010390894405, 010390894408, 010390894410, 020390958503, 030186208608, 030186208609, 030186208610,  030186208701, 030186208702, 030186208704, 030186208705, 030186208706, 030186208707, 030186208708, 030186208709, 030186208710, 030186208801, 030186208802, 030186208803,  030186208804, 030186208810, 030186208903, 040186294405, 040186453504, 040186453507, 040186453508, 040186453509, 040391134003, 040391134004, 040391134005, 040391134006,  040391134007, 040391134008, 040391134009, 050186453403, 050186453404, 050186453405, 050186453406, 050186453407, 050186453408, 050186453409, 050186453410, 050186453601,  050186453602, 050186453603, 050186453604, 050186453605, 050186453606, 050186453607, 050186453608, 050186453609, 050186453610, 050288869704, 050288869705, 050288869706,  050288869707, 050288869708, 050288869709, 050288869710, 050288888001, 050288888002, 050288888003, 050288888004, 050288888005, 050288888006, 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510290856203, 510290856204, 510290856205, 510290856206, 510290856207, 510290856209, 510290856210, 510290870301, 510290870302, 510290870303, 510290870304,  510290870305, 510290870306, 510290870307, 510290870308, 510290870309, 510393338901, 510393338902, 510393338903, 510393338904, 510393339106, 510393339108, 510393339109,  510393339110, 510393339201, 510393339202, 510393339204, 510393339205, 510393339206, 510393339207, 510393339210, 520086015001, 520086015002, 520086015003, 520086015004,  520086015005, 520086015006, 520086015007, 520086015008, 520086015009, 520086015010, 520086075701, 520086075702, 520086075703, 520086075704, 520086075705, 520086075706,  520086075707, 520393339305, 520393339306, 520393339308, 520393339309, GB040400313T, GB040400314T, GB040400315T, GB060402789T, GB060402790T, GB060403480T, GB060403481T, GB060403482T, GB060403483T, GB060403484T, GB060403485T, GB060403486T, GB060403487T, GB060403488T, GB060403489T, GB070404039T, GB080406583T, GB080406584T, GB080406586T,  GB080406587T, GB080406588T, GB080406589T, GB080406590T, GB090408369T, GB100409061T, GB100409062T, GB100409063T, GB100409064T, GB100409065T, GB110536258T, GB110536259T,  GB110536260T, GB110536261T, GB110536262T, GB110538376T, GB110538377T, GB110538378T, GB110538379T, GB110538380T, GB110538381T, GB120414431T, GB120414432T, GB120414434T,  GB120414435T, GB120538993T, GB120539982T, GB120539983T, GB120539984T, GB120539985T, GB120539986T, GB120539987T, GB120539988T, GB120539989T, GB120539990T, GB130415797T,  GB130415798T, GB130415799T, GB130415800T, GB130542463T, GB160423254T, GB160423255T, GB160423392T, GB160423393T, GB160423394T, GB160423395T, GB160423396T, GB160423398T,  GB170423901T, GB180426258T, GB180426259T, GB180426261T, GB180426263T, GB180426264T, GB180426265T, GB200430011T, GB200430012T, GB200430013T, GB200430014T, GB200430015T,  GB200430017T, GB200430018T, GB200430019T, GB200430020T, GB210430841T, GB210430842T, GB220434609T, GB220434610T, GB220434611T, GB240436836T, GB240436837T, GB240436838T,  GB240436839T, GB240437517T, GB240437518T, GB240438478T, GB240438479T, GB240438480T, GB270444518T, GB270444519T, GB270444520T, GB270444521T, GB280445596T, GB280446659T,  GB290447966T, GB290447967T, GB290447968T, GB290447969T, GB290447970T, GB290447971T, GB290447972T, GB290447973T, GB290447974T, GB290447975T, GB290448062T, GB290448063T,  GB290448064T, GB290448065T, GB290448066T, GB300448458T, GB300448459T, GB300449263T, GB300449265T, GB300449266T, GB300449267T, GB300449268T, GB300449269T, GB300449270T,  GB310450735T, GB320451842T, GB320451843T, GB320451844T, GB320451847T, GB320451849T, GB330453171T, GB330453172T, GB330453173T, GB330453176T, GB340455504T, GB340455505T,  GB400463858T, GB400463859T, GB400463860T, GB400463861T, GB400463862T, GB440473707T, GB440473708T, GB440473709T, GB440473710T, GB470479722T, GB470479723T, GB470479724T,  GB470479726T, GB470479727T, GB470479728T, GB470479729T, GB470479730T, GB470480473T, GB470480474T, GB470480475T, GB470480477T, GB470480478T, GB470480479T, GB470480480T,  GB470480481T, GB470480707T, GB470480708T, GB470480709T, GB470480710T, GB470480711T, GB470480712T, GB470480713T, GB470480714T, GB470480715T, GB480405320T, GB480405321T,  GB480405322T, GB480405323T, GB480405324T, GB480480963T, GB490407629T, GB490407630T, GB490407631T, GB490407632T, GB490407633T, GB490407634T, GB490407635T, GB490407636T,  GB490407637T, GB490407990T, GB490407991T, GB490407992T, GB490407993T, GB490407995T, GB490407996T, GB490407997T, GB490408366T, GB490408367T, GB490408368T, GB490408369T,  GB490408370T, GB490408371T, GB490408372T, GB490408373T, GB490408374T, GB490408375T, GB490408376T, GB490408377T, GB490408378T, GB490408379T, GB490408380T, GB490408381T,  GB490408382T, GB490408383T, GB490408384T, GB490408385T, GB490408386T, GB490408388T, GB490408389T, GB490408390T, GB490408391T, GB490408392T, GB490408393T, GB490408394T and  GB490408395T;  and Model KKB5042-21US, serial numbers 020493491301, 020493491303, 020493491304, 020493491305, 020493491306, 020493491307, 020493491308, 020493491309, 020493491310, 030288866910,  030493491401, 030493491402, 030493491403, 030493491404, 030493491406, 030493491407, 030493491409, 030493491410, 030493508001, 030493508002, 030493508003, 030493508004,  040391135105, 040391135106, 040391135107, 040391135108, 040391135109, 040391135201, 040391135202, 040391135203, 040391135205, 040391135206, 040391135207, 040391135208,  040391135209, 050391135305, 050391135306, 050391135307, 050391135308, 050391135309, 080391293604, 080391293605, 080391293606, 080391293607, 080391293608, 080391293609,  080391293610, 110289228210, 130289259601, 130289259602, 130289259603, 130289259604, 130289259605, 130289259606, 130289259607, 130289259608, 130289259610, 140391458801,  140391458802, 140391458803, 140391458804, 140391458805, 140391458806, 140391458807, 140391458808, 140391458809, 140391458810, 150289328401, 150289328402, 150289328403,  150289328404, 150289328405, 150289328406, 150289328407, 150289328408, 150289328409, 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450393031908, 450393031909, 450393031910, 450393032001, 450393032002, 450393032003, 450393032004, 450393032005, 450393032006,  450393032007, 450393032008, 450393032009, 450393032010, 460393032101, 460393032102, 460393032103, 460393032104, 460393032105, 460393032106, 460393032107, 460393032108,  460393032109, 460393032110, 460393032201, 460393032202, 460393032203, 460393032204, 460393032205, 460393032206, 460393032207, 460393032208, 460393032209, 460393032210,  460393054601, 460393054602, 460393054603, 460393054604, 460393054605, 460393054606, 460393054607, 460393054608, 460393054609, 460393054610, 470393054701, 470393054702,  470393054703, 470393054704, 470393054705, 470393054706, 470393054707, 470393054708, 470393054709, 470393054710, 480290856602, 480290856603, 480290856604, 480290856605,  480290856606, 480290856608, 480290856609, 480393099401, 480393099402, 480393099403, 480393099404, 480393099405, 480393099406, 480393099407, 480393099408, 480393099409,  480393099410, 480393118601, 480393118602, 480393118603, 480393118604, 480393118606, 480393118608, 480393118609, 480393118610, 490290856701, 490290856702, 490290856703,  490290856704, 490290856705, 490290856706, 490290856707, 490290856708, 490290856709, 490290856710, 490290856801, 490290856802, 490290856803, 490290856804, 490290856805,  490393118701, 490393118702, 490393118703, 490393118704, 490393118705, 490393118706, 490393118708, 490393118709, 490393118710, 500290856909, 500290856910, 500393181901,  500393181902, 500393181903, 500393181904, 500393181905, 500393181906, 500393181907, 500393181908, 500393181909, 500393181910, 500393182001, 500393182002, 500393182003,  500393182004, 500393182005, 500393182006, 500393182007, 500393182008, 500393182009, 500393182010, 500393182101, 500393182102, 500393182103, 500393182104, 500393182105,  500393182106, 500393182107, 500393182108, 500393182109, 500393182110, 500393182201, 500393182202, 500393182203, 500393182204, 500393182208, 500393182209, 500393182210,  510290856208, 510290889601, 510290889602, 510290889603, 510290889604, 510290889605, 510290889606, 510290889607, 510290889608, 510290889609, 510290889610, 510290962601,  510290962602, 510290962603, 510290962604, 520393240201, 520393240202, 520393240204, 520393240205, 520393240207, 520393240208, 520393240209, 520393240210, 520393252001,  520393252003, 520393252004, 520393252005, GB050401776T, GB050401777T, GB080529885T, GB080529886T, GB080529888T, GB080529889T, GB080529890T, GB080529891T, GB080529892T,  GB080529987T, GB090407796T, GB090407797T, GB090407800T, GB090407801T, GB090407802T, GB090407803T, GB110411528T, GB110412595T,GB110412600T, GB110412601T, GB110412602T,  GB110412603T, GB110536503T, GB110536508T, GB110536509T, GB110536511T, GB120413426T, GB120413427T, GB120413428T, GB120413429T, GB120413430T, GB120413431T, GB120413432T, GB120413433T, GB120413435T, GB120414028T, GB120414029T, GB120414032T, GB120414036T, GB120539683T, GB120539684T, GB120539685T, GB120539686T, GB120539687T, GB120539688T,  GB120539689T, GB120539690T, GB120539691T, GB120539692T, GB120540410T, GB120540411T, GB120540412T, GB120540413T, GB120540414T, GB120540415T, GB120540416T, GB120540417T,  GB120540418T, GB120540419T, GB130416187T, GB130416188T, GB130541692T, GB130541693T, GB130541694T, GB130541695T, GB130541697T, GB170424252T, GB170424253T, GB170424254T,  GB170424255T, GB170424256T, GB170424257T, GB170424258T, GB170424259T, GB170424260T, GB170424261T, GB170425010T, GB170425011T, GB170425012T, GB170425013T, GB170425014T,  GB170425015T, GB170425016T, GB170425017T, GB170425018T, GB170425019T, GB180426084T, GB180426089T, GB180426090T, GB180426091T, GB180426092T, GB180426093T, GB210431137T,  GB210431329T, GB210431330T, GB210431331T, GB210431332T, GB210431333T, GB210431334T, GB210431335T, GB210431338T, GB210432757T, GB210432758T, GB210432759T, GB210432760T,  GB210432761T, GB210432762T, GB210432763T, GB210432764T, GB210432765T, GB210432766T, GB220433638T, GB220433639T, GB220433640T, GB220433641T, GB220433642T, GB220433644T,  GB220433645T, GB220433647T, GB220434920T, GB220434921T, GB220434924T, GB220434925T, GB220434926T, GB220434928T, GB220434929T, GB240437972T, GB240438966T, GB240438967T,  GB240438968T, GB240438969T, GB240438970T, GB240438971T, GB240438973T, GB240438974T, GB240438975T, GB250439878T, GB250439879T, GB250439880T, GB250439881T, GB250439882T,  GB250439883T, GB250439884T, GB250439885T, GB250439886T, GB250439887T, GB260442005T, GB260442006T, GB260442007T, GB260442008T, GB260442009T, GB260442010T, GB260442011T,  GB260442012T, GB260442013T, GB260442014T, GB260443152T, GB260443153T, GB260443154T, GB260443161T, GB290448192T, GB290448193T, GB290448194T, GB290448195T, GB290448196T,  GB290448197T, GB360457211T, GB360457212T, GB360457213T, GB360457214T, GB360457215T, GB360457217T, GB360457218T, GB360457219T, GB380459822T, GB380459823T, GB380459824T,  GB380459825T, GB380459826T, GB380459827T, GB380459828T, GB380459829T, GB380459830T, GB410466960T, GB410467078T, GB410467079T, GB410467082T, GB410467084T, GB410467085T,  GB410467086T, GB410467087T, GB410467716T, GB410467717T, GB410467718T, GB410467724T, GB410467725T, GB470479364T, GB470479365T, GB470479366T, GB470479369T, GB470479370T,  GB470479372T, GB470479747T, GB470479748T, GB470479749T, GB470479750T, GB470479751T, GB470479752T, GB470479753T, GB480404852T, GB480404853T, GB480404854T, GB480404855T,  GB480404856T, GB480404858T, GB480404859T, GB500410418T, GB500410419T, GB500410420T, GB500410421T, GB500410422T, GB500410423T, GB500410424T, GB500410425T, GB500410426T,  GB500410427T, GB500411217T, GB500411218T, GB500411219T, GB500411220T, GB500411221T, GB500411222T, GB500411223T, GB500411224T, GB500411225T, GB500411226T, GB510411413T,  GB510411414T, GB510411415T, GB510411416T, GB510411417T, GB510411418T, GB510411419T, GB510411421T, GB510411422T, GB510411724T, GB510411726T, GB510411727T, GB510411728T,  GB510411729T, GB510411730T, GB510411731T, GB510411732T, GB510411733T, GB510413373T, GB510413374T and GB510413375T

General Hospital and Personal Use Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey

Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. || The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.

Bard Peripheral Vascular: Bard Max-Core disposable core biopsy instrument

Radiology Devices

2

No

Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, JORDAN, KAZAKHASTAN, KOREA, LEBANON, LITHUANIA, MACEDONIA, MALYASIA, MALI, MAURITIUS, MEXICO, MALDOVA, MOSCOW, NYNMAR, NAMBIA, NAMIRGIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGER, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILLIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RUSSIAN FEDERATION, SAUDI ARABIA, SENEGAL, SERBIA, SEBIA AND MONROBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOMALIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBERKISTAN, VENEZUELA, VIETNAM and YEMEN.

Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 || The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.