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2004年2月4日作成
医療用具回収の概要
（クラスII）
1. 一般名及び販売名
一般的名称：滅菌済み血管診断用チューブ及びカテーテル
販売名：ファンサックカテーテル
承認番号：２０２００ＢＺＺ０００１９０００
承認年月日：平成２年１月１６日
2. 対象ロット、数量及び出荷時期
品番 型式 ロット
K5117 FA5F-38B-110-4PIGUEDA K01030058900 K01050044700 K01080089300 K01090120401 K01120032400 K02020133700 K02050163400 K02110136600 K03020128300 K03070034900
K01030105500 K01060129500 K01080103600 K01090139200 K02010032900 K02050036600 K02080054800 K03010043600 K03050066600 K03070125300
K01030105501 K01060136800 K01090120400 K01110038800 K02020037500 K02050149500 K02110052500 K03010085600 K03060068800 K03090030700
K01030112000 K01080025700
K5118 FA5F-38B-110-10PIGA
K01030038300 K01050144500 K01090011900 K01120041001 K02030142800 K02070070100 K02100127000 K03020088300 K03050040800 K03070174400
K01030047700 K01060014800 K01090033300 K01120094800 K02030152700 K02080010800 K02100140500 K03020098800 K03050170300 K03090030400
K01030066700 K01070031300 K01090062500 K01120101200 K02040018400 K02080043000 K02100173900 K03020105800 K03050190200 K03090048300
K01040052600 K01070040700 K01100066800 K01120107800 K02050009100 K02080168000 K02120023300 K03020119100 K03060010300 K03090061300
K01040061100 K01070064000 K01100146000 K01120109600 K02050019800 K02090012100 K02120142300 K03030159300 K03060040800 K03090151400
K01040118400 K01070089900 K01100155000 K02010113000 K02050131600 K02090019200 K02120173300 K03040001400 K03070044200 K03090172100
K01040128700 K01070098600 K01100155001 K02010127400 K02050131601 K02090050900 K03010008700 K03040019500 K03070064300 K03090202000
K01040141700 K01070105400 K01110004500 K02020001300 K02050156000 K02100075600 K03010191300 K03040043400 K03070130500 K03100011300
K01040148900 K01070105401 K01110015000 K02030033300 K02060001300 K02100099400 K03020017200 K03040166100 K03070142300 K03100117900
K01050010600 K01070117900 K01120003000 K02030059700 K02060011900 K02100115200 K03020040600 K03050000800 K03070144100 K03100136600
K01050118900 K01070132300 K01120022000 K02030111900 K02070021600 K02100115201 K03020069700 K03050027500 K03070161400 K03100162700
K01050135300 K01070148700 K01120041000 K02030127700 K02070043600 K02100118000
K5135 FA5F-38B-90-10PIGA K01030047800 K01090146000 K01110092800 K02020065200 K02060094000 K02070186300 K02090051000 K02110033600 K02120001600 K03100061600
K01030139600 K01100078900 K01120095100
K5138 FA5F-38B-110-10PIGF-A K01030131800 K01060031800 K01080035600 K01100067000 K02020003300 K02040066000 K02050156100 K02060110201 K02080123200 K02110033700
K01050024500 K01060090200 K01090043200 K01120125100 K02020119600 K02050024500 K02060110200 K02070146100 K02100072400 K02110120300
K5189 FA5F-38B-110-10PIG K01030048000 K01040083300 K01080064500 K02050060600 K02100100100 K03020047600 K03090004500 K03100042900 K03100205700 K03110185800
K01030131900 K01060097300 K02020108900 K02090069300 K02120065200 K03040052100 K03090156200
K5190 FA5F-38B-80-10PIGA K01050114400 K02010106900 K02070095600 K02090029700 K02120073300 K03010014500 K03020146800 K03040158100 K03070115200 K03090051400
K01070034500 K02050013800 K02080012500 K02110212000
K5195 FA5F-38B-80-10PIG K01090005000
K5247 FA5F-38B-110-6PIGAMU1 K01030066800 K01050034000 K01070025200 K01100109100 K02090093700 K02100175600 K03030093100 K03050048200 K03080006600 K03090039300
K01040025500 K01050112500 K01090062700 K02060127300 K02100142800 K02120067400
K5285 FA5F-38B-100-MD6PIGF-G K03020087300
K5305 FA5F-38R-130-10PIGA-J K01040027300 K01060110700 K02050075600 K02080012600 K02100062800 K03020072600 K03050057600 K03070177400 K03090083100 K03110060300
K01040095700 K01090021600 K02060013800 K02080119300 K02110014200 K03030016100 K03050166700 K03080072400 K03100043000 K03120137400
K01050065700 K01110164500 K02060080700 K02090036700 K02110100200 K03040025300 K03070055400 K03080143200 K03100165700 K03120186500
K01060024200 K02010098000 K02070086900 K02100023300 K03010174800
K5514 2FA5F-38B-70-10PIG K01050001800 K01090062800 K02030069200 K02060018900 K02060110301 K02100199200 K02110098100 K03030075000 K03090013700 K03110170100
K01060075300 K01120086900 K02040054500 K02060110300 K02090028000 K02110067900 K03010002400 K03060069100 K03100095400 K03120093000
K01080056000 K02010081800 K02040151700
K5625 2FA5F-38B-90-10PIG K01040043200 K01060123800 K01090052800 K01100128900 K02010022000 K02040066300 K02060001400 K03010025100 K03020083400 K03060079800
K01040083400 K01080064600 K01100046900 K01110138900 K02030026500 K02040160600 K02070029900 K03020047800 K03040101500 K03080048200
K01060041200
K5626 2FA5F-38B-110-10PIG K01050068500 K01050071800 K01060068900 K01110118300 K02100101800 K02100136600 K02100192500 K02110100300
K5633 2FA5F-38B-80-10PIG K01040095900 K01050065800 K02020039700 K02030028300 K02060090000 K02060127400
K573301 FA5F-38A-90-B-YMK-TN K01080115200 K03080125700 K03090105500 K03100176300
K573502 FA5F-38A-110-B-10PIG-KR-0.5S K03040153800
K573503 FA5F-38A-110-B-20PIGH2-0.5S K01020105900 K01030092700 K01080142200 K01100047200 K01110047800 K01110062600 K01110062601 K02010022100 K02020026000 K02030001100
K575501 FA5F-38B-70-B-10PIG K02040125300
K575901 FA5F-38B-110-B-4PIGUEDA0.7S K02020020900 K02030125400 K02040016200 K02050117000 K02070006400 K02080104900 K03010079600 K03080136500
K575902 FA5F-38B-110-B-4PIGUEDA-SN K01030032300 K01060147600 K01080111500 K02010033200 K02050072000 K02060101400 K02070115900 K02110025800 K03010172800 K03050085300
K01040001600 K01070009000 K01090146100 K02020043900 K02050073900 K02060125400 K02070137800 K02110049300 K03030071000 K03060068500
K01040076500 K01070156000 K01100017400 K02030049300 K02050094200 K02060125401 K02090001400 K02120034600 K03030129200 K03070051900
K01040094000 K01080011000 K01100115600 K02030049301 K02050103700 K02060143400 K02090028100 K03010034500 K03030151300 K03090035900
K01040094001 K01080011001 K01100129000 K02040048500 K02050118400 K02070085300 K02090059700 K03010119800 K03030168600 K03090191200
K01050084000 K01080073400 K01110077200 K02040092300 K02050140300 K02070100300 K02100049500 K03010152300 K03050055300 K03090210900
K01050090900 K01080095000 K01110103700 K02040099500 K02060078400 K02070108100 K02100072500 K03010164000 K03050055301 K03100192000
K01050097900 K01080095001 K01110115700 K02040111500
K575904 FA5F-38B-110-B-20PIG-0.5S K01030024900 K01060032000 K01080136101 K01110139000 K02030069300 K02050070100 K03010106600 K03050014200 K03080029500 K03090091500
K01030119600 K01070064200 K01100001500 K01120065400 K02040077000 K02070020200 K03020083100 K03060049500 K03090061800 K03110016000
K01050063900 K01080136100 K01110029700 K02020003400 K02050043100 K02120173600 K03040009500 K03070061600
K597202 FA5F-38B-115-B-20PIG-0.5S K02070026100 K02070028300
K6041 FA6F-38B-110-4PIGUEDA K01020112800 K01040036100 K01100057100 K02020026200 K02030105100 K02070036400 K02120071400 K03020024300 K03030168700 K03070009600
K01020123900 K01070125200 K01110029900 K02020055600 K02030110100 K02080018900 K02120098300 K03020024400 K03030168701 K03080002900
K01030009500 K01070134600 K01110048000 K02030039500 K02050043200 K02090035300 K03010098700 K03030053100 K03050095500 K03080093800
K01030112200 K01080159500 K01110048001 K02030039501 K02050060700 K02100040000 K03010119900 K03030114000 K03060079300 K03080130200
K01030146800 K01090020800 K01120032700 K02030069400 K02060032800 K02120034900 K03020017300 K03030143300 K03060193300 K03100028900
K01040008300 K01100038500 K02010029900 K02030096200 K02060048300
K6058 FA6F-38B-110-4PIGUEDA-S K01020106100 K01050018800 K01080056300 K01110004700 K02010001000 K02080028100 K02110140500 K03020002600 K03040183100 K03080188800
K01020119100 K01050034400 K01080056301 K01110022600 K02010008100 K02080055100 K02110155900 K03020026100 K03060086600 K03090091200
K01020129600 K01050054300 K01080064700 K01110022601 K02010105200 K02080117800 K02110166100 K03020056700 K03060165900 K03090101200
K01030002100 K01060007000 K01090001300 K01110062800 K02010127600 K02080135800 K02110194000 K03030035200 K03060177800 K03090110500
K01030025000 K01060023300 K01090027100 K01110085300 K02010145500 K02080155500 K02110210100 K03030042000 K03070001200 K03090120100
K01030124500 K01060050200 K01090053000 K01110109900 K02020016800 K02100001400 K03010024800 K03030070800 K03080019200 K03100105300
K01030151600 K01060155000 K01090131200 K01110109901 K02020126100 K02100031200 K03010043300 K03040080700 K03080044000 K03100128500
K01030151601 K01070002000 K01100001700 K01110123700 K02020140300 K02100199400 K03010062700 K03040155300 K03080105800 K03100145300
K01040043500 K01070009100 K01100028000 K01110132200 K02030003400 K02110001400 K03010184400 K03040166200 K03080138900 K03100145301
K01040061400 K01070017900 K01100150700 K01120130500 K02070061200 K02110012400 K03010184401 K03040168000 K03080165300 K03100170400
K01050002000 K01080036000 K01100163200 K01120142800
K6072 FA6F-38B-110-10PIGA K01040132200 K01040145300 K01060009800 K02020007100 K02020020500
K6087 FA6F-38B-110-10PIG K01040150200 K01050004600 K01060050300 K01060155100 K01070083400
K6201 FA6F-38R-130-10PIGA K01110059300 K01120135000 K02050161000 K02060113300
K6515 2FA6F-38ZS-80-IK-TN K01070028200 K01070028201 K01080076600 K02040024001 K02050004100
K6528 2FA6F-38ZS-80-IK4-TN K01070028300 K01080107200
K5323 FA5F-38R-130-10PIG1A K01080144800 K02030035900 K02100111700 K02120107600 K03030080900 K03030171300 K03040187000 K03050031100 K03060081800 K03070100500
K02010003900 K02090023300 K02100138500 K03030017800 K03030155300
K532407 FA5F-38R-130-10PIG-J K03050099400 K03060100200 K03090097000 K03100045400
出荷総数：１８，５２７本（合計）
出荷時期：平成１３年４月１０日 〜 平成１６年２月２日
3. 製造業者等名称
製造業者：株式会社クリニカル・サプライ
住所：岐阜県羽島郡川島町竹早町３番地
業許可番号：２１ＢＺ００２０号（医療用具製造業）
4. 回収理由
医療機関より、本カテーテルの先端部が縦方向に裂けたという不具合報告を受けました。
弊社にて現品及び原材料を調査したところ、該当製品の一部型式において同様の不具合発生の可能性を否定できないため、製品の自主回収を実施いたします。
5. 危惧される具体的な健康被害
カテーテル先端部に縦方向の亀裂が生じた場合、ガイドワイヤーでカテーテルの形状を伸ばすことが困難になり、血管壁損傷等の恐れがありますが、
医師はＸ線透視下において異常を確認することができ、また先端部は柔軟なソフトチューブであるため、慎重に抜去することで、重篤な健康被害を回避することが出来ます。
また、亀裂の発生はチューブ成型時の樹脂の融合部である縦方向に限られており、円周方向(横方向）に脆弱な部分は生じないため離断する可能性はありません。
なお、当該不具合においてこれまでに健康被害の報告は受けておりません。
6. 回収開始年月日
平成１６年２月４日
7. 効能・効果又は用途等
血管造影を行うために血管内に挿入するカテーテルです。
8. その他
納入先の代理店並びに医療機関はすべて把握しており、平成１６年２月４日付けで使用中止の依頼を口頭並びに文書にて通知し、回収を行います。
9. 担当者名及び連絡先
連絡先：株式会社クリニカル・サプライ
岐阜県羽島郡川島町竹早町３番地
研究開発部薬制室 山内、土屋
ＴＥＬ ０５８６−８９−４５３３
ＦＡＸ ０５８６−８９−４１６２
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