Events

Merit Medical Surgical Convenience Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merit Medical Systems, 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
    38950
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1262-2007
  • 사례 시작날짜
    2007-08-15
  • 사례 출판 날짜
    2007-09-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54603
  • 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
    Surgical Convenience Kits - Product Code LRO
  • 원인
    Expiration dating; some convenience kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.
  • 조치
    An August 22, 2007, Product Correction/Removal letter was issued to all distributors requesting return of affected lots and sub recall notification to their consignees.

Device

Merit Medical Surgical Convenience Kits
  • 모델명 / 제조번호(시리얼번호)
    Merit Lot Numbers: A339685, A342805, A343855, A344934, A348869, A350784, A350904, A353811, A355556, A357384, A357617, A358608, A360773, A361301, A364800,A365752, A366125, A366523, A367651, A371190, A372815, A374857, A375138, A375848, A376973, A377976, A381997, A384786, A387975, F390117, F399800, F406192, F434870, F440785, F440789, F440801, F440803, F442051, F449479, F449481, F449482, F449483, F453020, F453170, F455150, F456553, F465539, F465540, F470421, F471056, F471659, F473566, F474320, F476314, F476367, F476543, F476597, F477729, F480127, F480129, F480131, F480140, F482129, F482853, F488460, F488709, F488858, F489432, F491275, F491462, F491656, F491659, F492220, F492223, F494547, F495828, F496118, F496939, F502345, F504184, F505776, F505782, F505785, F505786, F505790, F505794, F505799, F508595, F509197, F511015, F513651, F514433, F514954, F514957, F515853, F517537, F517708, F518306, F520504, F523595, F526626, F528413, F534059, F536871, F537731, F538716, F548977, F548978.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • 제조사 주소
    Merit Medical Systems, Inc, 1600 West Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA