Cardinal Health Custom Sterlie Convenience Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 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
    33767
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0163-06
  • 사례 시작날짜
    2005-10-03
  • 사례 출판 날짜
    2005-11-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2006-12-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    General Surgery Tray - Product Code LRO
  • 원인
    The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex.
  • 조치
    Cardinal Health notified the accounts who ordered the affected packs via letter dated 10/3/05, informing them that the packs that were labeled latex-free actually contained an elastic bandage that contained latex rubber. The letters were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to telephone Cardinal Customer Service at 1-800-964-5227 for return instructions for the affected packs return to Cardinal Health for replacement.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cat. POOCOTFGB, order numbers 9904815, 9911445, 9911446, 9923559, 9926928, 9929035 and 9932551; Cat.SOP22ARCLC, order number 144191;  Cat. SOP30ARCOB, order number 704460;  Cat. SOP30ARCOC, order numbers 713043 and 717623;  Cat. SOP30ARKGC, order number 716550;  Cat. SOP30ARMCB, order numbers 708643 and 717298;  Cat. SOP30ARNOA, order number 728554;  Cat. SOP30KANRA, order number 708579;  Cat. SOP30LENHC, order numbers 702865 and 714615;  Cat. SOP30SADTE, order number 717371;  Cat. SOP30THDTD, order number 715392;  Cat. SOP30THNOA, order number 728333;  Cat. SOP30THSJA, order number 710742;  Cat. SOP30TKSJA, order number 709389;  Cat. SOP30THVCH, order numbers 709885 and 719564;  Cat. SOP30TKVCE, order numbers 703408 and 716341
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    South Carolina, New York, Nebraska, Florida and internationally to Canada
  • 제품 설명
    Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: || a) Cat. POOCOTFGB - Sterile Ortho Pack || b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack || c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack || d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack || e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk || f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack || g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack || h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack || i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk || j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack || k) Cat. SOP30THDTD - Sterile Total Hip Pack || l) Cat. SOP30THNOA - Sterile Total Hip Pk || m) Cat. SOP30THSJA - Sterile Total Hip Pack || n) Cat. SOP30TKSJA - Sterile Total Knee Pack || o) Cat. SOP30THVCH - Sterile Total Hip Pack || p) Cat. SOP30TKVCE - Sterile Total Knee Pack
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardinal Health, 1430 Waukegan Rd, McGaw Park IL 60085
  • Source
    USFDA