Events

Device Recall KimberlyClark, Three Quarter Drape 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Kimberly-Clark Corporation 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
    59161
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2836-2011
  • 사례 시작날짜
    2011-06-06
  • 사례 출판 날짜
    2011-07-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101449
  • 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
    Surgical Drape - Product Code KKX
  • 원인
    Metal shavings were found within the folded portion of the surgical drape.
  • 조치
    Kimberly-Clark Corporation sent an "Urgent: Voluntary Product Recall" letter dated June 6, 2011 to all affected customers and a subsequent letter dated June 22, 2011. The letter notified them of the recall and provided recommendations. They were instructed to evaluate their facilities unused inventory of the affected drapes to determine if any of the impacted product lots remain with their facility. If present, they were to quarantine and discontinue use. A Customer Product Recall Response Form was included to be completed and faxed to KC. They will be contacted by a representative regarding the return and replenishment of the product. If the product was further distributed, the consignee was advised to contact the end user, make them aware of the recall and to retrieve any of the affected product in inventory. For additional information please contact Kimberly-Clark Regulatory Affairs at 770-587-7400.

Device

Device Recall KimberlyClark, Three Quarter Drape
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 79147 Lot numbers: AC1080052, AC1093104, AC1094061, AC1098193, AC1099073, AC1099213, AC1099074, AC1100074, AC1105054, AC 1124031, AC1124092, AC1126173, AC 1127013, AC 1128153, AC1129031, AC1129062, AC1130011, AC1130092, AC1082042, AC1089111, AC1102021 AC1102141, AC1103031, AC1104101, AC1106103, AC1106164, AC1107084, AC1121184, AC1122071, AC1122192, AC1123012, AC1125111, AC1131082, AC1131092, AC1131151, AC1134133.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide (USA) distribution, including the states of CA, FL, GA, IA, IL, MO, NC, NY, OH, TN, TX, VA and WI.
  • 제품 설명
    Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, || Surgical drape.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • 제조사 주소
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA