Events

Device Recall Hamilton Soft Grip Pipettes, 1 ml adjustable volume 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hamilton Co 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
    48425
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2233-2008
  • 사례 시작날짜
    2008-05-07
  • 사례 출판 날짜
    2008-09-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71360
  • 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
    Pipette - Product Code JQW
  • 원인
    Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity.
  • 조치
    Recall initiated May 7 2008. Notification issued via certified overnight mail explains the problem and instructs customers to inventory the affected pipettes. The firm will contact its customers and supply replacement lower-body assemblies, repair instructions and return information so that affected parts can be returned to Hamilton. A fax-back form is supplied with each notification. Responses will be tracked. Contact Hamilton Co. at 1-775-558-3000 for assistance.

Device

Device Recall Hamilton Soft Grip Pipettes, 1 ml adjustable volume
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 63045, 63098, 63135, 63157, 63208, 63248, 63278, 63378, 63401, 63418, 63421, 63442, 63461, 63485, 63524, 63527, 63590, 63679, 63753, 63788, 63804, 63820, 63825, 63834, 63836, 63848, 63857, 63885, 63892, 63904, 63951, 63989, 63993, 64047, 64057, 64074, 64076, 64093, 64140, 64160, 64242, 64246, 64261, 64279, 64288, 64289, 64314, 64342, 64352, 64362, 64399, 64407, 64427, 64478, 64479, 64480, 64492, 64498, 64504, 64507, 64518, 64520, 64525, 64527, 64528, 64537, 64538, 64543, 64544, 64563, 64577, 64582, 64585, 64587, 64590, 64592, 64599, 64612, 64628, 64631, 64635, 64636, 64644, 64667, 64678, 64694, 64695, 64703, 64706, 64718, 64720, 64722, 64723, 64729, 64740, 64753 64757, 64759, 64760, 64763, 64767, 64772, 64778, 64785, 64787, 64789, 64792, 64797, 64801, 64810, 65015, 65016, 65018, 65067, 65068, 65071, 65076, 65078, 65079, 65080, 65083, 65090, 65091, 65109, 65119, 65186, 65204, 65224, 65262, 65269, 65290, 65514, 65536, 65541, 65564, 65566, 65567, 65568, 65575, 65576, 65578, 65583, 65590, 65591, 65597, 65600, 65603, 65608, 65609, 65610, 65612, 65614, 65617, 65622, 65623, 65626, 65628, 65631, 65632, 65635, 65644, 65650, 65655, 65657, 65662, 65678, 65692, 65701, 65705, 65707, 65726, 65747, 65771, 65772, 65773, 65777, 65836, 65858, 65906, 65910, 65916, 65917, 65918, 65921, 65925, 65926, 65927, 65929, 65930, 65933, 65935, 65936, 65938, 65946, 65947, 65952, 65953, 65959, 65961, 65964, 65966, 65973, 65979, 65981, 65982, 65983, 65987, 65993, 65995, 65996, 65997, 65998, 65999, 66000, 66002, 66007, 66008, 66013, 66014, 66015, 66016, 66017, 66019, 66062, 66079, 66088, 66104, 66107, 66115, 66124, 66138, 66145, 66174, 66182, 66196, 66197, 66198, 66201, 66205, 66210, 66222, 66226, 66233, 66252, 66253, 66270, 66286, 66289, 66296, 66305, 66309, 66341, 66342, 66345, 66351, 66353, 66361, 66366, 66372, 66373, 66380, 66397, 66398, 66400, 66402, 66403, 66404, 66417, 66418, 66422, 66423, 66425, 66426, 66431, 66434, 66436, 66438, 66443, 66444, 66448, 66450, 66452, 66453, 66456, 66463, 66465, 66474, 66475, 66480, 66483, 66484, 66488, 66490, 66496, 66497, 66503, 66504, 66505, 66512, 66517, 66519, 66520, 66522, 66523, 66534, 66535, 66538, 66540, 66548, 66549, 66550, 66552, 66555, 66556, 66557, 66558, 66560, 66562, 66565, 66567, 66568, 66569, 66573, 66574, 66576, 66577, 66578, 66582, 66584, 66591, 66601, 66603, 66605, 66607, and 66612
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product distributed throughout the US and to Puerto Rico, New Zealand, Australia, Japan and Canada.
  • 제품 설명
    Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40 || Product is indicated for manual pipetting.
  • Manufacturer
    Hamilton Co

Manufacturer

Hamilton Co
  • 제조사 주소
    Hamilton Co, 4970 Energy Way, Reno NV 89502-4123
  • Source
    USFDA