Device Recall Presource PBDS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health, Medical Products & Services 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
    64736
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1194-2013
  • 사례 시작날짜
    2013-03-26
  • 사례 출판 날짜
    2013-05-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-04-12
  • 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
    Anesthesia breathing circuit kit - Product Code OFP
  • 원인
    Various presource kits contain a pre-assembled filter and anesthesia circuit that may contain outer plastic packaging on one or more components. if the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
  • 조치
    Affected consignees were notified with a letter, dated March 26, 2013, sent via FedEx Priority, of this action. Cardinal Sales Representatives will also be advised and will verbally communicate the action to affected customers. The letter identified the affected product and the problem. Customers are to locate any affected product and quarantine them. In addition, clinicians should be informed of the issue; and, warning labels should be affixed to the front of each kit instructing users to remove and discard the Anesthesia Circuit and Filter Assembly. In order to confirm receipt of this action and completion of labeling the product, the enclosed Acknowledgement Form should be completed and returned to the number provided. If customers do now wish to accept overlabeled product or to overlabel the product in their possession, they are to contact Presource Sales Operations at 800-766-0706, or their sales representative for further instruction. Customers are to contact Cardinal Health Quality Systems at 800-292-9332, if they have any questions or need special assistance.

Device

  • 모델명 / 제조번호(시리얼번호)
    A) Catalog Number: PG24LCGWG02; Lots: 153502, 162892, 170494, 180482 88701, 193548, 198163, 206986;   B) Catalog Number: PG24LCGWG; Lots:153502, 162892, 170494, 180482, 188701, 193548, 198163, 206986
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of AR, MS, SC, and TN.
  • 제품 설명
    A) Presource PBDS, Lap Chole, Kit, Clean Up; || B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardinal Health, Medical Products & Services, 1430 Waukegan Road, Attn V. Mueller Qa, Park City IL 60085
  • 제조사 모회사 (2017)
  • Source
    USFDA