FRAZIER Atraumatic Soft Tip Surgical Suction Instrument, 10 French 20/C 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Conmed Corporation 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
    45862
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0558-2008
  • 사례 시작날짜
    2007-09-12
  • 사례 출판 날짜
    2008-02-02
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Laparoscope - Product Code GCJ
  • 원인
    Sterility (package integrity) compromised -- frazier and poole suction instruments may have an inadequate seal. the product pouch seal made during assembly of this product, may be incomplete or not present.
  • 조치
    URGENT-Device Recall Letters (dated 9/10/07) and FIELD CORRECTIVE ACTION CERTIFICATION forms were sent via Certified Mail to affected customers the week of 9/09/07 (mailed on 9/12/07). The recall letters informed the consignees of the recall due to potentially inadequate seals of the instruments, and instructed them to review their inventory of the instruments checking them for inadequate seals. The letters also instructed the consignees to complete the form and fax it back by 9/21/07. For those consignees that have any of the recalled instruments or may have questions, please contact ConMed Quality Assurance at 1-800-552-0138 ext. 5225 between the hours of 7 am - 6 pm (MST). International customers were notified on 9/18/07. A second recall letter (dated 10/09/07) was sent to non-respondents of the initial mailing. ConMed plans to send a third recall letter to the non-responders during the week of 12/10/07 which addresses sub-recall notifications to the distributors' customers.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product Code: 0031100; All lot codes manufactured between 10/04/06 and 7/31/07 (lots 061004 through 070731). Lot codes on boxes and packaging contain a 6 digit lot code: For example, lot 061004: the first 2 digits represent the year manufactured (06 represents 2006), next 2 digits represent the month (10 represents October), the next 2 digits represent the day of the month (04).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Worldwide Distribution
  • 제품 설명
    FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator, 10 French, Product Code: 0031100, 20/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
  • Manufacturer

Manufacturer

  • 제조사 주소
    Conmed Corporation, 525 French Road, Utica NY 13502-5945
  • Source
    USFDA