Events

Device Recall ARROW Antimicrobial/Antithrombogenic PICC Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arrow International Inc 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
    76637
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1705-2017
  • 사례 시작날짜
    2017-03-03
  • 사례 출판 날짜
    2017-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-02-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153712
  • 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
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • 원인
    Arrow international, inc. notified its customers who received the affected antimicrobial/antithrombogenic picc kits, that the kits were being recalled due to a labeling error. the lidstock on some of the kits reads cdc-45541-hpk1a, while the banner card on the side of the kit reads cdc-45052-hpk1a. other kits may list cdc-45052-hpk1a on the lidstock and cdc-45541-hpk1a on the banner card. the affected lot numbers are 23f16c0851, 23f16a0727, and 23f16c0844.
  • 조치
    Arrow International mailed an Urgent Medical Device Recall Notification letter to affected customers on March 7, 2017, to inform them of the issue. The notification informs customers to discontinue use and quarantine any products identified with the specific lot numbers. Customers are asked to complete the enclosed Recall Acknowledgement Form for product return. For further questions, please call (866) 246-6990.

Device

Device Recall ARROW Antimicrobial/Antithrombogenic PICC Kits
  • 모델명 / 제조번호(시리얼번호)
    Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution
  • 제품 설명
    The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • 제조사 주소
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA