Events

Sure Temp Plus Model 690/692 Oral Temperature Probes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Welch Allyn 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
    28030
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0354-04
  • 사례 시작날짜
    2003-12-30
  • 사례 출판 날짜
    2004-01-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31069
  • 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
    Thermometer, Electronic, Clinical - Product Code FLL
  • 원인
    Mechanical setting errors that result in calibration errors.
  • 조치
    Recall letters dated 12/29/2003 were sent to all customers requesting quarantine and subrecall if needed. Consignees are to request return authorization for replacement.

Device

Sure Temp Plus Model 690/692 Oral Temperature Probes
  • 모델명 / 제조번호(시리얼번호)
    Welch Allyn¿ Part #s: 0690-XXX Serial Numbers/Lot Numbers 02692-000 Oral Probe 4 ft. 412003-442003, 472003, 522003-582003. 02692-100 Oral Probe 9 ft. 412003-442003, 472003, 522003-582003 02893-000 Oral Probe Well Kit 4 ft. 412003-442003, 472003, 522003-582003 02893-100 Oral Probe Well Kit 9 ft. 412003-442003, 472003, 522003-582003    Probes are contained in Welch Allyn¿ Thermometer Boxes with Part #s: 0690-XXX Serial Numbers/Lot Numbers 01690-000 03397655 - 03505486 01690-200 03397655 - 03505486 E-01690-200 03397655 - 03505486 01690-300 03397655 - 03505486 01690-400 03397655 - 03505486 01690-410 03397655 - 03505486 01690-500 03397655 - 03505486 E-01692-200 03397655 - 03505486 01692-200 03397655 - 03505486 01692-300 03397655 - 03505486 01692-400 03397655 - 03505486 01692-500 03397655 - 03505486 01692-700 03397655 - 03505486    Probes are contained in Welch Allyn¿ Vital Signs Monitor III boxes with Part#s: Serial Numbers/Lot Numbers 53NTO-E1 JA000244, JA000282, JA000283, JA000284,  JA000285, JA000286, JA000287, JA000288, JA000289, JA000290, JA000291, JA000292, JA000293, JA000294, JA000295, JA000296, JA000297, JA000298, JA000299, JA000300, JA000301, JA000302, JA000303, JA000304, JA000305, JA000306, JA000307, JA000308, JA000309, JA000310, JA000311, JA000312, JA000313, JA000314, JA000315, JA000316, JA000317, JA000318, JA000319, JA000320, JA000331, JA000332, JA000333, JA000334, JA000335, JA000336, JA000337, JA000340, JA000341, JA000342, JA000343, JA000344, JA000345, JA000347, JA000348, JA000349, JA000352, JA000353, JA000354 53NTP-E1 JA000232, JA000243, JA000246, JA000255, JA000258, JA000259, JA000271, JA000278, JA000281, JA000326, JA000327, JA000328, JA000357
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Sure Temp Plus Model 690/692 Oral Temperature Probes
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc
  • 제조사 주소
    Welch Allyn Inc, 7420 Carroll Rd, San Diego CA 92121-2334
  • Source
    USFDA