Device Recall Bondek Absorbable Sutures 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Telefelx Medical 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
    54474
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2286-2010
  • 사례 시작날짜
    2010-02-01
  • 사례 출판 날짜
    2010-08-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-04-19
  • 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
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • 원인
    Labeling error; the bondek suture product inside the box are of a different catalog number than labeled on the outer box.
  • 조치
    Teleflex Medical issued consignees a "Urgent Medical Device Recall" letter dated February 1, 2010. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. The letter described the packaging issue and potential impact. Customers were instructed to immediately discontinue use and quarantine any identified products, complete and fax the Recall Acknowledgement Form to 866-804-9881, in order to receive a Return Goods Authorization (RGA) Number, and then return the product to Teleflex Medical for replacement. Affected products received by Teleflex Medical will be destroyed upon receipt.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: EP4084N, Lot number: 02A0801449
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: USA and Germany
  • 제품 설명
    Deknatel Bondek¿ Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in general surgical procedures where general soft tissue approximation and/or ligation are performed, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • 제조사 모회사 (2017)
  • Source
    USFDA