Events

Surgidyne SVac round fluted channel silicone drain 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Aspen Surgical Products, 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
    51898
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1638-2009
  • 사례 시작날짜
    2009-04-13
  • 사례 출판 날짜
    2009-05-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-11-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81606
  • 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
    Surgidyne S-Vac round fluted channel silicone drain - Product Code GCY
  • 원인
    An adaptor, which may be required when connecting the drain to an external device, was not included in the package.
  • 조치
    An "Urgent Medical Device recall" letter dated April 13, 2009 was issued to consignees via certified mail. The letter described the affected product. and actions for customers. Consignees were instructed to carry out the recall to the retail level and to quarantine and return the product to Aspen Surgical Products, Inc. Consignees were also instructed to complete the enclosed response form and return it via mail, fax or e-mail. Direct questions about the recall by calling Aspen Surgical Products, Inc. at 1-616-698-7100, extension 142 or extension 141.

Device

Surgidyne SVac round fluted channel silicone drain
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 2014-02-13.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri.
  • 제품 설명
    Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. || The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
  • Manufacturer
    Aspen Surgical Products, Inc.

Manufacturer

Aspen Surgical Products, Inc.
  • 제조사 주소
    Aspen Surgical Products, Inc., 6945 Southbelt Dr Se, Caledonia MI 49316-7664
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA