Events

Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48'' 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Deroyal Surgical -Rose Hill 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
    30045
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1493-04
  • 사례 시작날짜
    2004-09-09
  • 사례 출판 날짜
    2004-09-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-05-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35071
  • 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
    Drape, Surgical - Product Code KKX
  • 원인
    Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
  • 조치
    The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.

Device

Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
  • 모델명 / 제조번호(시리얼번호)
    Lot: 1007212 1030172  1030181  1142043  1225324  1225332  1225341  1225359  1306298  1330669  1330677  1341190  1375832  1375841  1375867  1375875  1407072  1431304  1521772  1543672  1543681  1627016  1634152  1678542  1678606  1736079  1736087  1736095  1736108  1736116  1800384  1800608  1876426  1911375  1911421  2055689  2075217  2136454  2136471  2268684  2375877  728683  783421  805360  805378  805482  825555  900762  900797  900800  974681  974729
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
  • 제품 설명
    Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
  • Manufacturer
    Deroyal Surgical -Rose Hill

Manufacturer

Deroyal Surgical -Rose Hill
  • 제조사 주소
    Deroyal Surgical -Rose Hill, 100 Rose Hill Industrial Park, Rose Hill VA 24281
  • Source
    USFDA