Hudson RCI 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    69658
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0505-2015
  • 사례 시작날짜
    2014-09-03
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-08-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Humidifier nebulizer kit - Product Code OGG
  • 원인
    Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
  • 조치
    Customers were notified of the recall by letter on September 3, 2014. The letter requested that they discontinue distribution and quarantine the products and return the products to Teleflex. The letter also requested a sub-recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product No. 403728, Lot #104120, 114120, 132120, 120120, 155120, 158120, 144120, 164120, 008130, 013130, 023130, 035130, 038130, 049130, 060130, 072130, 054130, 100130, 115130, 128130, 142130 & 020140; Product No. 404128, Lot #065123, 068123, 051123, 077123, 060123, 087123, 005133, 082123, 035133, 029133, 048133, 053133, 056133, 063133, 068133, 076133, 083133, 055123 & 052123; Product No. 404428, Lot #041124, 080124, 002134, 085124, 009134, 019134, 025134, 035134, 049134, 039134, 044134, 056134, 061134, 060134, 003144 & 046124; Product No. 037-28, Lot #083120, 069120, 081120, 068120, 050120, 024120, 023120, 030120, 040120, 042120, 031120, 041120, 051120, 049120, 053120, 052120, 064120, 070120, 071120, 075120, 072120, 078120, 077120, 080120, 034123, 129120, 082120, 084120, 079120, 067120, 076120, 092120, 090120, 094120, 096120, 085120, 091120, 131120, 130120, 095120, 133120, 138120, 097120, 145120, 098120, 134120, 139120, 147120, 146120, 141120, 151120, 152120, 153120, 157120, 159120, 160120, 173120, 166120, 167120, 172120, 174120, 004130, 002130, 177120, 007130, 006130, 005130, 015130, 019130, 010130, 011130, 017130, 016130, 020130, 018130, 021130, 033130, 022130, 024130, 025130, 026130, 036130, 028130, 032130, 027130, 040130, 051130, 041130, 042130, 050130, 052130, 062130, 063130, 064130, 066130, 067130, 077130, 073130, 074130, 075130, 078130, 089130, 118130, 090130, 091130, 119130, 092130, 102130, 103130, 104130, 113130, 110130, 111130, 112130, 114130 & 117130; Product No. 037-28C, Lot #073120, 103120, 093120, 142120, 162120, 012130, 055120, 061130, 039130, 121130, 105120, 169120, 170120, 034130, 099130, 003130, 071130 & 076130; Product No. 037-28F, Lot #140120, 143120, 106120, 119120, 165120, 085130, 161120, 116130, 129130, 045140, 120140 & 128140; Product No. 037-33, Lot #094120, 049120, 074120, 067120, 113120, 123120, 121120, 157120, 172120, 177120, 015130, 032130, 036130, 040130, 089130, 101130, 102130 & 117130; Product No. 037-35, Lot #002220, 004220, 006220, 001220, 065120, 005220 & 007220; Product No. 037-39, Lot #008320, 004320, 010320, 005320, 009320, 016320 & 002330; Product No. 037-39C, Lot # 006320 & 007320; Product No. 037-70, Lot #005220 & 007220; Product No. 041-28, Lot #006123, 007123, 016123, 017123, 018123, 035123, 034123, 027123, 039123, 040123, 028123, 026123, 046123, 047123, 045123, 048123, 053123, 062123, 063123, 064123, 069123, 080123, 070123, 056123, 071123, 072123, 081123, 057123, 075123, 076123, 074123, 058123, 083123, 088123, 089123, 090123, 003133, 084123, 004133, 006133, 011133, 012133, 013133, 023133, 021133, 025133, 026133, 027133, 031133, 032133, 037133, 038133, 039133, 042133, 044133, 043133, 045133, 051133, 050133, 058133, 059133, 062133, 060133, 066133, 064133, 065133 & 061133; Product No. 041-28C, Lot #008123, 015123, 022123, 042123, 086123, 007133, 033123, 022133, 040133, 067133, 066123, 028133 & 030133; Product No. 041-33, Lot #006123, 021123, 029123, 036123, 048123, 053123, 064123, 058123, 085123, 091123, 025133, 042133, 051133, 052133, 062133, 058133 & 041133; Product No. 041-35, Lot #001223, 002223, 001233, 003223 & 003233; Product No. 044-28, Lot #038124, 008124, 011124, 014124, 012124, 013124, 032124, 037124, 033124, 064124, 066124, 065124, 073124, 061124, 074124, 076124, 039124, 060124, 083124, 081124, 077124, 084124, 006134, 011134, 012134, 013134, 017134, 016134, 023134, 024134, 029134, 030134, 032134, 033134, 036134, 045134, 037134, 051134, 057134 & 052134; Product No. 044-28C, Lot #009124, 020124, 078124, 008134, 048124, 026134, 035124, 062124, 018134 & 055134; Product No. 044-28F, Lot #040124, 063124, 067124, 049124, 079124, 003134, 050134, 004144, 010144, 017144, 022144 & 030144; Product No. 044-33, Lot #045124, 018124, 019124, 033124, 034124, 064124, 050124, 077124, 060124, 084124, 007134, 004134, 033134, 037134, 045134, 052134 & 057134; Product No. 044-35, Lot #001224, 003224, 004224, 005224, 006224, 001234, 002234 & 003234; Product No. 044-70, Lot #001234.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, and the countries of United Arab Emirates, Australia, Belgium, Brazil, Canada, Chile, China, France, Great Britain, Japan, India, Indonesia, Israel, South Korea, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Uruguay, and Zambia.
  • 제품 설명
    Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. || Used in anesthesiology.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • 제조사 모회사 (2017)
  • Source
    USFDA