Events

Device Recall CADD(R) Medication Cassette with clamp and female Luer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical ASD 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
    77555
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3071-2017
  • 사례 시작날짜
    2017-06-05
  • 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=156494
  • 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
    Pump, infusion - Product Code FRN
  • 원인
    The medication cassette reservoir, part number 21-7002-24, with lot number 16x659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed incorrectly.
  • 조치
    Consignees (may include distributors and hospitals) in Japan were notified the week of June 5, 2017. Recall letters were delivered by Smiths Medical, Japan sales representatives during the week of 06/19/2017. The consignees were directed to return any affected devices in their possession and receive replacements. Their Smiths Medical sales representative will collect the affected product and replacement product will be sent to them.

Device

Device Recall CADD(R) Medication Cassette with clamp and female Luer
  • 모델명 / 제조번호(시리얼번호)
    lot number 16X659
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Japan, China, US
  • 제품 설명
    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • 제조사 주소
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • 제조사 모회사 (2017)
    Smiths Group Plc
  • Source
    USFDA