Events

Sensicare Green Polyisoprene Surgical Glove with Aloe Vera, Size 8.5, MSH1285, Lot Number 7018933694 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medline Industries 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
    78464
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0162-2018
  • 사례 시작날짜
    2017-10-23
  • 사례 출판 날짜
    2017-11-21
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159624
  • 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
    Surgeon's gloves - Product Code KGO
  • 원인
    Possible open seal on top portion of the package. could cause breach of sterility.
  • 조치
    Medline Industries sent an Immediate Action Required Letter dated October 23, 2017, to all affected customers.. Instructions included to check inventory and quarantine affected product, complete and return the response form to Medline, arrange for the return of any affected product, and notify any customers if the product was further distributed. Customers with questions were instructed to call 866-359-1704.

Device

Sensicare Green Polyisoprene Surgical Glove with Aloe Vera, Size 8.5, MSH1285, Lot Number 7018933694
  • 모델명 / 제조번호(시리얼번호)
    Model No. MSG1285, Lot No. 701893369485
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.
  • 제품 설명
    Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. || Surgical glove.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • 제조사 주소
    Medline Industries Inc, Three Lakes Drive, Northfield IL 60093
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA