Events

Device Recall Circumcision Clamp, models 1.1cm and 1.3cm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Surgical Design 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
    58318
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2153-2011
  • 사례 시작날짜
    2011-01-26
  • 사례 출판 날짜
    2011-05-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98978
  • 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
    Circumcision Clamp - Product Code HFX
  • 원인
    Medical device used in surgical procedure is defective and may break during use.
  • 조치
    Surgical Design, Inc. sent a Customer letter dated February 23, 2011, informing them of the affected product and providing instructions for its specific consignees. The instructions to the User is to please check your inventory to determine whether any Circumcision Clamps bought directly match those on your shelves. Please fill out the form and mail it to Surgical Design at the address on the form. If any clamps from the affected lots remain in your inventory, please ship them back to Surgical Design, noting the number being returned on the Reply form. These are the affected Lots. 100210 (1.3cm) 100211 (1.1cm) and 100060409 (1.3cm) If you have any further questions, please call (703) 541-0196.

Device

Device Recall Circumcision Clamp, models 1.1cm and 1.3cm
  • 모델명 / 제조번호(시리얼번호)
    Lots: 100210 (1.3 cm),  100211 (1.1 cm), 100060409 (1.3 cm)
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class 2 Recall -- Nationwide Distribution.
  • 제품 설명
    Circumcision Clamp, models 1.1 cm and 1.3 cm, || Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
  • Manufacturer
    Surgical Design Inc

Manufacturer

Surgical Design Inc
  • 제조사 주소
    Surgical Design Inc, 7351 Lockport Pl Ste D, Lorton VA 22079-1571
  • 제조사 모회사 (2017)
    Surgical Design Inc.
  • Source
    USFDA