Events

Device Recall Diaphragm (contraceptive device) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cooper Surgical, 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
    64510
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1018-2013
  • 사례 시작날짜
    2013-02-26
  • 사례 출판 날짜
    2013-03-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116371
  • 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
    Diaphragm, contraceptive (and accessories) - Product Code HDW
  • 원인
    Incorrect size was printed on the outer product packaging.
  • 조치
    CSI notified consignees affected by this recall by a Recall Notification letter, dated February 26, 2013, sent via Federal Express with confirmed delivery receipt. The letter identified the affected product, and asked customers to contact the firm's Customer Service Department at 1-800-243-2974, if they had any of the affected lot in their inventory. Customers also have the option of completing the form attached to the letter and faxing it back to 800-262-0105. At CooperSurgical's expense, arrangements will made to replace the affected products that customers have on hand. The firm will provide further instruction and disposition of the product at the time of replacement.

Device

Device Recall Diaphragm (contraceptive device)
  • 모델명 / 제조번호(시리얼번호)
    Lot 113367
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.
  • 제품 설명
    Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 || Intended for use in contraception.
  • Manufacturer
    Cooper Surgical, Inc.

Manufacturer

Cooper Surgical, Inc.
  • 제조사 주소
    Cooper Surgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • 제조사 모회사 (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA