Device Recall 7mm Drain Kit Flat Full Perforated with Trocar and 100ml SVac Bulb Evacuator, Sterile (10/case) 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
    67757
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1434-2014
  • 사례 시작날짜
    2014-03-20
  • 사례 출판 날짜
    2014-04-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-11-25
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • 원인
    The recall has been initiated due to a potential compromise of the sterile barrier of the surgidyne wound drainage and surgidyne bulb evacuator & collection system medical devices.
  • 조치
    Aspen Surgical sent an Urgent Medical Device Recall letter dated March 20, 2014, to all affected customers and will be carried out at the distributor and retailer level, which can include doctor's offices, hospitals, and clinics. The distributor was instructed to contact their local FDA District office, conduct a sub-recall and to forward this Recall Notification and Response form to their retailers. A written notification to the consignees was sent by certified mail. Aspen has given the customers the option to either 1.) Return the product 2.) Destroy the product with a Certificate of Destruction to be provided to Aspen. Any returned product to Aspen will be put on MRB and dispositioned by Quality. The returned product will not be reprocessed. In order to determine effectiveness of the recall, any consignee that does not return the response form and/or product, will be contacted within three weeks of receipt of the Recall letter. Non-responders will be contacted a total of three (3) times in order to verify the effectiveness of the recall activity. Customers with questions were instructed to call 888-364-7004, ext 177 or 1-888-364-7004, ext. 156. For questions regarding this recall call 616-698-7100.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product Number 340002
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
  • 제품 설명
    7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) || Intended for closed wound suction drainage
  • Manufacturer

Manufacturer

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