Device Recall Boston Scientific PT2 Guide Wire

  • 모델명 / 제조번호(시리얼번호)
    Single Pack - Outer Box UPN H7492893102J0, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616992/8498451; 8634476/8576268; 8637834/8592512; 8642641/8542687; 8687373/8644753; 8687380/8620072; 8693389/8644751.   5-pack - Outer Box UPN H7493893102J2, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616993/8498451; 8619932/8428652; 8634477/8576268; 8637835/8592512; 8642642/8542687; 8687374/8644753; 8687381/8620072; 8693471/8644751; 8745684/8677736.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
  • 제품 설명
    Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

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  • 모델명 / 제조번호(시리얼번호)
    Single Pack - Outer Box UPN H7493893101J0, Inner Pouch UPN H7493893101J0 with the following Outer Box Batch number / Inner Pouch Batch number: 854993/8506164; 8553464/8506163; 8558452/8506162; 8580516/8418120; 8581252/8414121; 8601289/8567104; 8601977/7567103; 8611497/8390776; 8618382/8414119; 8625209/8525244; 8630091/8602645; 8630092/8599793; 8637044/8599796; 8639684/8602647; 8642791/8599795; 8643583/8616749; 8645466/8616759; 8646331/8616971; 8650221/8599794; 8656280/8616970; 8656289/8612088; 8662274/8599797; 8662896/8616760; 8666532/8632041; 8668106/8602646; 8669915/8642147; 8681003/8641004; 8684067/89641006; 8694117/8642148; 8697663/8525245; 8699505/8642146; 8709594/8519073; 8749798/8713578; 8752423/8695650; 8761674/8721471; 8762199/8721350; 8774436/8742235; 8782981/8755555; 8783262/8742236; 8784950/8739386; 8795581/8755557; 8797321/8757433.   5-pack - Outer Box UPN H7493893101J2, Inner Pouch UPN H7493893101J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8553465/8506163; 8558453/8506162; 8642073/8607723; 8642792/8599795; 8643584/8616749; 8645467/8616759; 8646332/8616971; 8646667/8607724; 8650220/8599794; 8654220/8612089; 8656281/8616970; 8656290/8612088; 8662275/8599797; 8667578/8641003; 8668107/8602646; 8669916/8642147; 8677642/8519074; 8681004/8641004; 8683824/8530667; 8696525/8642150; 8697664/8525245; 8699506/8642146; 8776585/8739387.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
  • 제품 설명
    Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Single Pack - Outer Box UPN H7493893103J0, Inner Pouch UPN H7493893103J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8447584/8424370; 8541995/8510188; 8544020/8510187; 8577183/8503242; 8577293/8503244; 8577534/8333665; 8579728/8418259; 8580421/8406879; 8580887/8475378; 8580917/8475377; 8581079/8530796; 8585386/8503269; 8587755/8503243; 8588197/8503270; 8588877/8388791; 8591438/8376779; 8592293/8418258; 8592533/8414114; 8593589/8559710; 8593596/8539572; 8594060/8559712; 8597428/8539574; 8597830/8556834; 8598870/8388789; 8600066/8559711; 8600420/8564504; 8602812/8564506; 8603659/8567100; 8606749/8389080; 8606923/8567101; 8607935/8579186; 8607935/8556836; 8608015/8579186; 8614864/8580832; 8614869/8424371; 8615879/8567099; 8616669/8539573; 8620583/8596274; 8620754/8475382; 8628574/8596276; 8628912/8580831; 8630440/8596275; 8636284/8602641; 8636415/8602640; 8649768/8607727; 8650600/8602642; 8652901/8607728; 8654225/8602643; 8654227/8607725; 8670952/8530791; 8676700/8635975; 8685522/8649203; 8690104/8635973; 8698011/8635340; 8698012/8635972; 8698293/8653545; 8699510/8635341; 8699989/8530668; 8701815/8635976; 8702228/8530797; 8710305/8556838; 8711647/8649204; 8711691/8653546; 8711815/8661235; 8712096/8665816; 8712099/8530790; 8716342/8653547; 8722177/8683665; 8722191/8693297; 8722301/8665815; 8730052/8665814; 8731234/8695647; 8733364/8683670; 8734071/8691635; 8740494/8687514; 8741462/8661234; 8745691/8687516; 8748547/8693296; 8749063/8695649; 8750426/8708960; 8753228/8683668; 8754548/8693298; 8758129/8708968; 8758432/8719088; 8759720/8691637; 8764914/8721351; 8766444/8721352; 8766905/8708969; 8769690/8718984; 8769944/8695646; 8773040/8708966; 8773153/8691639; 8775975/8719089; 8776994/8744947; 8783863/8708965; 8784103/8708958; 8784392/8756635; 8785597/8756634; 8788048/8687515; 8789999/8760871; 8793576/8743903; 8794952/8767167; 8797558/8744946; 8798246/8760865; 8800605/8760864; 8801108/8744945.   5-pack - Outer Box UPN H7493893103J2, Inner Pouch UPN H7493893103J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8447685/8424370; 8541998/8510188; 8544019/8510187; 8577096/8475380; 8577182/8503242; 8577294/8503244; 8577535/8333665; 8580409/8418259; 8580422/8406879; 8580888/8475378; 8580918/8475377; 8581080/8530796; 8592294/8418258; 8592534/8414114; 8593591/8559710; 8593597/8539572; 8594061/8559712; 8597829/8539574; 8597831/8556834; 8598871/8388789; 8600065/8559711; 8602822/8564506; 8603658/8567100; 8606831/8389080; 8606924/8567101; 8607936/8579186; 8607936/8556836; 8608018/8579186; 8614865/8580832; 8615130/8424371; 8615880/8567099; 8616668/8539573; 8617431/8580830; 8620755/8475382; 8630441/8596275; 8636285/8602641; 8636416/8602640; 8640730/8596273; 8649767/8607727; 8650599/8602642; 8652900/8607728; 8654224/8602643; 8654226/8607725; 8676701/8635975; 8677779/8635342; 8698294/8653545; 8699851/8635341; 8699990/8530668; 8701816/8635976; 8702229/8530797; 8711692/8653546; 8711816/8661235; 8712098/8665816; 8712100/8530790; 8716343/8653547; 8722178/8683665; 8722302/8665815; 8722332/8693297; 8731237/8695647; 8733366/8683670; 8734132/8691635; 8740495/8687514; 8741463/8661234; 8748549/8693296; 8749065/8695649; 8750427/8708960; 8753229/8683668; 8754545/8708967; 8754549/8693298; 8758131/8708968; 8758433/8719088; 8759722/8691637; 8764915/8721351; 8766445/8721352; 8773154/8691639; 8774030/8743905; 8775976/8719089; 8776995/8744947; 8779683/8743904; 8783864/8708965; 8784104/8708958; 8784393/8756635; 8785598/8756634; 8788047/8687515; 8793578/8743903; 8794953/8767167; 8797559/8744946; 8798247/8760865; 8800606/8760864; 8801109/8744945.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
  • 제품 설명
    Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Single Pack - Outer Box UPN H7493893104J0, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578445/8498450; 8615997/8579187; 8616986/8428651; 8625889/8542669; 8634387/8592510; 8661236/8615192; 8676306/8623927; 8679477/8614968; 8684638/8614969; 8691987/8614967; 8711404/8615194; 8711707/8640992; 8716167/8615190; 8775301/8721349.     5-Pack - Outer Box UPN H7493893104J2, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578446/8498450; 8615998/8579187; 8616987/8428651; 8625890/8542669; 8634388/8592510; 8661241/8615192; 8676307/8623927; 8679478/8614968; 8684639/8614969; 8691990/8614967; 8711405/8615194; 8711708/8640992; 8716168/8615190; 8775302/8721349.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
  • 제품 설명
    Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
  • Manufacturer