Events

KimberlyClark RadiOpaque Radiofrequency Cannula 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
    66832
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0850-2014
  • 사례 시작날짜
    2013-10-29
  • 사례 출판 날짜
    2014-01-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123686
  • 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
    Probe, radiofrequency lesion - Product Code GXI
  • 원인
    Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
  • 조치
    The firm, Kimberly-Clark Corporation, sent an "URGENT: Voluntary Medical Device Recall Notification" letter dated October 29, 2013 to all direct customers and distributors via federal express priority overnight. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate your Facility's inventory of Kimberly-Clark RadiOpaque Radiofrequency Cannula to determine if any of the two impacted product lots remain within your facility. If product is present, discontinue use of the impacted product and place in a quarantined location; complete and return the attached Product Recall Response Form-Customers via fax to: 1-920-225-4182 within five (5) business days of receipt of this letter (complete and return form even if either of the impacted product lots is NOT present in your facility). Once response form is received, a Kimberly-Clark representative will contact you regarding return and replacement of the product. If you require further assistance, please call Kimberly-Clark Customer Service at 800-KC-HELPS (800-524-3577).

Device

KimberlyClark RadiOpaque Radiofrequency Cannula
  • 모델명 / 제조번호(시리얼번호)
    Lot M3085K301 and M2327K301
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.
  • 제품 설명
    Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 || The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • 제조사 주소
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076-2190
  • 제조사 모회사 (2017)
    Kimberly-Clark Corporation
  • Source
    USFDA