Events

Device Recall Kimberly Clark/Ballard Medical Pain Management Procedural Trays 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
    35158
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0869-06
  • 사례 시작날짜
    2006-03-15
  • 사례 출판 날짜
    2006-05-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45428
  • 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
    Anesthesia Conduction Kit - Product Code CAZ
  • 원인
    Procedural trays may contain extension sets that do not meet usp specification requirements for non pyrogenicity (less than or equal to 2.25 eu/device (endotoxin units/device).
  • 조치
    Consignees were notified via fax on/about 03/15/2006.

Device

Device Recall Kimberly Clark/Ballard Medical Pain Management Procedural Trays
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 181000, Lot #324507, Product Code: 181053, Lot #325536 Product Code: 181066, Lot #327295, Product Code: 181069, Lot #326447 & Lot #330094, Product Code: 181126, Lot #327296, Product Code: 181128, Lot #324516, Product Code: 181167, Lot #319874, Product Code: 181253, Lot #326455, Product Code: 181255, Lot #330100, Product Code: 181269, Lot #326456, Product Code: 181A055, Lot #329119, Product Code: 181A088, Lot #328354 and  Product Code: 181A237, Lot #329220
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide. AK, AL, CA, CO, CT, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, OK, OR, PA, TX, UT, WA, WI.
  • 제품 설명
    Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

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