Events

Device Recall Biogel Skinsense 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Molnlycke Health Care, 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
    39362
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1219-2007
  • 사례 시작날짜
    2007-07-20
  • 사례 출판 날짜
    2007-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-03-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55283
  • 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
  • 원인
    Sterility compromised (package integrity): the primary packaging for a portion of the lot may contain gloves that were not sealed properly.
  • 조치
    Consignees were notified by registered mail on 07/23/2007. The notice contained a Recall Response Form to confirm receipt of the notice and to verify if the product is still in inventory. The notice instructed to consignee to inspect their inventory for Biogel Skinsense Polyisoprene Surgical Gove, lot #07B026, Size 8. If this lot and size are in their inventory, they were instructed to discontinue use, quarantine the product and return the product to Molnlycke Healthcare.

Device

Device Recall Biogel Skinsense
  • 모델명 / 제조번호(시리얼번호)
    Lot #07B026, Size 8
  • 유통
    Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI
  • 제품 설명
    Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia
  • Manufacturer
    Molnlycke Health Care, Inc

Manufacturer

Molnlycke Health Care, Inc
  • 제조사 주소
    Molnlycke Health Care, Inc, 5550 Peachtree Pkwy Ste 500, Norcross GA 30092-2555
  • 제조사 모회사 (2017)
    Investor AB
  • Source
    USFDA