Events

Nylon Surgical Suture 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Riverpoint Medical, LLC 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
    74891
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2761-2016
  • 사례 시작날짜
    2016-08-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148694
  • 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, nonabsorbable, synthetic, polyamide - Product Code GAR
  • 원인
    Nylon surgical sutures are recalled because the seals may become open during distribution or subsequent packaging.
  • 조치
    Riverpoint Medical sent an Urgent Medical Device letter, dated August 5. 2016, and the Customer Response Form to their customers via email. The letter identified the affected product, problem and actions to be taken. Customers are instructed to check inventory, discontinue selling affected sutures and return affected devices to the firm. Distributors are instructed to notify their downstream customers. Consignees should submit the Customer Response Forms. For questions call Riverpoint Medical at 1-866-445-4929.

Device

Nylon Surgical Suture
  • 모델명 / 제조번호(시리얼번호)
    Lot For human use:  160210-02.  Lots For Vet use:  160223-03V 160302-06V 160202-01V 160217-02V 160224-03V 160218-03V 160204-01
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
  • 제품 설명
    Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: || 663BK || 663BL || 664BL || 928BK || Product Usage: || For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
  • Manufacturer
    Riverpoint Medical, LLC

Manufacturer

Riverpoint Medical, LLC
  • 제조사 주소
    Riverpoint Medical, LLC, 825 NE 25th Ave, Portland OR 97232-2304
  • 제조사 모회사 (2017)
    Riverpoint Medical LLC
  • Source
    USFDA