Events

Device Recall UNIVERSAL FLEX2 BREATHING CIRCUIT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 King Systems Corp. dba Ambu, Inc. 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
    78799
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0321-2018
  • 사례 시작날짜
    2017-03-15
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160526
  • 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
    Filter, bacterial, breathing-circuit - Product Code CAH
  • 원인
    Potential for leak test failures.
  • 조치
    On 3/15/2017, the firm issued a letter to its sales force describing its intent to replace product for consignees that complained about leaking. The firm also issued a copy of the manifold IFU that includes the need for a 1/4 turn in the Universal Flex2 Breathing Circuit (with bacterial filter).

Device

Device Recall UNIVERSAL FLEX2 BREATHING CIRCUIT
  • 모델명 / 제조번호(시리얼번호)
    1960762 1960765 1960769 1960784 1960787 1960788 1960789 1960792 1960800 1960803 1960804 1961934 1961935 1961936 1961937 1961938 1961940 1961941 1961942 1961943 1961945 1961946 1961951 1961952 1961953 1961956 1961957 1961960 1962253 1962254 1962256 1962260 1962261 1962263 1962264 1962265 1962266 1962359 1962360 1962366 1962368 1962596 1962609 1962612 1962613 1962614 1962615 1962849 1962852 1962853 1962855 1962890 1962891 1962892 1962893 1962895 1964378 1964379 1964380 1964381 1964383 1964392 1964394 1964396 1964399 1964400 1964677 1964680 1964699 1964813 1964819 1964822 1964825 1964984 1965377 1965379 1965386 1965391 1965393 1965394 1965919 1965920 1965921 1965923 1965924 1965926 1965927 1965928 1965929 1965930 1965931 1965933 1965939 1965943 1965946 1965954 1965956 1965957 1965958 1965960 1965961 1965962 1965963 1966701 1966702 1966703 1966704 1966706 1966707 1967262 1967265 1967266 1967267 1967268 1967269 1967276 1967382 1967523 1967525 1967526 1967528 1967549 1967550 1967551 1967552 1967553 1967554 1968687 1968689 1968691 1968692 1968693 1968694 1968695 1968696 1968698 1968704 1968706 1968707 1968708 1968709 1968725 1968726 1968727 1968728 1968729 1968730 1968874 1968875 1968877 1968879 1968881 1968882 1968883 1968892 1968897 1968898 1969450 1969451 1969452 1969453 1969454 1969467 1969468 1969470 1970330 1970382 1970837 1970882 1970907 1970909 1970911 1970912 1970913 1970914 1970915 1970916 1970917 1970918 1970921 1970924 1970926 1970927 1970929 1970930 1970931 1970932 1970933 1971683 1971684 1971688 1971689 1971690 1971691 1971692 1971693 1971694 1971696 1971698 1971699 1971706 1971707 1971708 1971709 1971710 1971711 1971713 1971714 1971716 1971724 1971725 1971726 1971727 1971729 1971730 1971731 1971735 1971736 1971737 1971738 1972360 1972362 1972363 1972365 1972372 1972376 1972377 1972378 1972379 1972381 1972382 1972386 1972388 1972389 1972391 1972392 1972393 1972394 1972399 1972830 1972831 1972832 1972833 1972835 1972836 1972837 1972840 1972841 1972843 1972844 1972845 1972850 1972852 1972853 1973970 1973972 1973977 1973986 1974000 1974002 1974546 1974549 1974550 1974551 1974684 1974780 1975089 1975090 1975091 1975092 1975093 1975096 1975097 1975098 1975104 1975109 1975110 1975111 1975112 1975115 1975118 1975119 1975120 1975122 1976072 1976073 1976074 1976075 1976084 1976085 1976086 1976087 1976718 1976728 1976729 1976730 1976733 1976734 1976735 1976736 1976737 1976739 1976934 1976942 1976943 1976946 1976947 1976960 1976962 1977030 1977034 1977053 1977151 1977168 1977176 1977177 1977865 1977903 1977904 1977905 1977909 1977911 1977912 1977913 1977915 1977917 1977920 1977921 1977923 1977924 1977926 1977928 1977932 1977933 1977934 1978739 1978795 1978796 1978797 1978798 1978799 1978801 1978802 1978806 1978807 1978808 1978835 1978836 1978838 1978839 1979219 1979238 1979239 1979240 1979241 1979242 1979243 1979244 1979245 1979259 1979342 1979343 1979346 1979370 1979372 1979875 1979890 1979895 1979898 1979899 1979900 1979901 1979902 1979903 1979904 1979906 1979907 1979908 1980972 1980973 1980975 1980976 1980978 1980987 1980991 1980995 1980998 1980999 1981001 1981002 1981004 1981005 1981006 1981007 1981008 1981009 1981010 1981011 1981022 1981398 1981399 1981455 1981456 1981457 1981458 1981459 1981463 1981465 1981469 1982117 1982125 1982126 1982129 1982130 1982132 1982133 1982136 1982137 1982138 1982140 1982142 1982144 1982147 1982148 1982149 1982151 1982157 1982158 1982159 1982161 1983477 1983482 1983486 1984094 1984097 1984098 1984099 1984103 1984104 1984105 1984268 1984269 1984270 1984271 1984273 1984275 1984277 1984278 1984285 1984286 1984290 1984291 1984293 1984294 1984295 1984296 1984297 1985618 1985620 1985621 1985624 1985625 1985632 1985633 1985636 1985637 1985638 1985639 1985960 1985961 1985962 1985978 1986136 1986137 1986138 1986141 1986142 1986143 1986220 1986221 1986222 1986228 1986229 1986230 1986300 1986350 1986360 1986407 1986408 1986409 1986410 1986415 1986418 1986419 1986420 1986421 1986422 1986425 1986426 1986427 1986428 1986429 1986430 1987316 1987317 1987318 1987325 1987659 1987660 1987663 1987664 1987669 1987911 1987915 1987917 1987918 1987919 1987920 1987921 1987923 1987924 1987930 1987932 1988003 1988004 1988005 1988008 1988011 1988368 1988374 1988375 1988376 1988380 1988381 1989233 1989234 1989235 1989236 1990044 1990045 1990046 1992003 1992024 1992025 1992026 1992341 1992343 1992344 1992348 1992360 1992362 1992363
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution Pattern  Distributors in 44 states: Al, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI WY; International Pattern - Canada, China, Chile
  • 제품 설명
    UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z, DF375-6121Z, DF470-6021Z, D366-618Z, D390-60Z, D390-61Z, DP260-61, DF370-6121Z, D3120-6154Z, F95100, JD365-6033Z, DF370-61Z, DF475-61Z, DF3110-6121Z, DF3110-6121Z, DF375-6121Z, DF475-6121Z, F90755, F90798, F95368, PDP260-61, D396R-61Z, F90578, F90622Z, F94980, D360-61Z, D365-6121Z, D366-6121Z, D366-6121Z, SJDF3116-6121Z, DF375-6121Z, DF470-6121Z, DF470-61Z, DF475-6121Z, DF375-6033Z, DF375-618Z, DF470-6127Z, DF475-61Z, DF476-6121Z, F90756, PDB160-6131, PDP160-6121, PDY160-6121, D060-8021, D366-8021Z, D466-6121Z, DF370-6121Z, DF470-6121Z, DF376-6121Z, PDP160-6031, D360-8021Z, D360-80Z, D445-80Z, D465-8021Z, JD365-6033Z, D460-6131Z, D460-6133Z, DF475-6121Z, DF3116S-608Z, F90777, D360-6133Z, D365-80Z, D360-6021Z, D360-6121Z, D360-61Z, DF3110-61Z, DF370-61Z, DF375-17621Z, DF475-6121Z, D365-6121Z, D060-80, PD060-6121, PD160-6121Z, PDP160-6121, DF3115-6121Z, F90767, DF375-17621Z, DF375-6121Z, DF470-6121Z, PD260-61Z, PDY140-6133, D360-16421Z, D360-6121Z, D366-6121Z, DFP2110-6121, DF470-6121Z, D465-8021Z, DF4115-6121Z, DF370-6121Z, DF376-6121Z, PDB140-61, D365-6121Z, DF070-61, PDY160-6121, D365-61Z, D360-6121Z, D360-61Z, D460-6121Z, DF0110-6121, DF3110-61Z, DF370-61Z, DF375-6121Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF370-6021Z, DF370-6133Z, DF375-618Z, DF475-17621Z, DFB170-61, PD040-61, PDP160-6121, PDY160-6121, D390-61Z, F94474, D460-61Z, D366-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, DF0110-61, DF0110-61, DF3115-6121Z, DF3115-6121Z, DF070-6127, F90752, DF375-17621Z, DF375-61Z, DF376-17621Z, F95100, D360-6021Z, D366-6121Z, D465-8021Z, D360-61Z, DF3110-61Z, DF3110-61Z, DF3110-6121Z, PDP160-6031, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D460-61Z, D3120-6121Z, D360-8021Z, D365-80Z, D395-8021Z, D460-8021Z, D465-8021Z, D495-61Z, F90577Z, DF370-6133Z, DF375-6021Z, DF376-6121Z, DF475V-6121Z, DFP170-6121, DF370-61Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-61Z, DF3115-6121Z, F90767, DF370-6121Z, DF375-6121Z, DF476-6121Z, F95407, F90556, D365V-8021Z, F95383, D460-61Z, F90777, DF370-6121Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, D440-80Z, D360-6021Z, D365-6121Z, DF370-61Z, DF4116-6121Z, DF476-6121Z, F90579, D345-6121Z, D396R-61Z, D460-80Z, D465-6031Z, D465-8021Z, DP2120-61, F90578, F94795, F94980, D360-61Z D365-6121Z, D365-6121Z, D366-6121Z, D366-6121Z, D460-6121Z, D460-6121Z, D460-61Z, D360-6021Z, D360-6121Z, D366-6121Z, D366-6121Z, D060-8021, D3120-6121Z, D360-16421Z, D360-8021Z, D360-8031Z, D366-80Z, D390-61Z, D460-80Z, D465-8021Z, D465V-8021Z, PDP160-6121, DF070-6121, DF370-6021Z, DF375-61Z, DF375-61Z, DF375-61Z, DF470-6021Z, DF475-61Z, DFY170-6121, DF375-17621Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF475-6121Z, SJDF3116-6121Z, DF3115-6121Z, DF3116-6121Z, DF4115-6121Z, DF4116-6121Z, DF475-6121Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF0110-618, DF370-61Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF375-6021Z, F90798, PDP140-6121, D365V-8021Z, D366-8021Z, D445-80Z, D460-8021Z, D460-8021Z, D465-61Z, D365-61Z, DF3116S-608Z, DF370-6121Z, DF375-17621Z, DF375-6121Z, DF470-6127Z, DF475V-6121Z, DF476-6121Z, F95368, F95407, PD060-61, PDB160-6131, PDP160-6121, D460-6131Z, D360-6121Z, D360-61Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, DF376-17621Z, D3120-6121Z, D466-6121Z, DF4110-6121Z, DF370-6121Z, DF376-6121Z, DF475V-6121Z, D440-80Z, DF376R-61Z, DF0110-6121, DF370-6121Z, DF470-6121Z, DF375-17621Z, DF370-6021Z, DF475-61Z, DFP170-6121, DFY270-6121, PDP264C-61, D360-8021Z, D365-8021Z, D365-80Z, D365-80Z, F90578, D360-6121Z, D360-6121Z, D360-61Z, D460-6121Z, DF3115-6121Z, DF3115-6121Z, DF4115-61Z, DFP2110-61, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF476-6121Z, DF470-6121Z, DF475V-6
  • Manufacturer
    King Systems Corp. dba Ambu, Inc.

Manufacturer

King Systems Corp. dba Ambu, Inc.
  • 제조사 주소
    King Systems Corp. dba Ambu, Inc., 15011 Herriman Blvd, Noblesville IN 46060-4253
  • Source
    USFDA